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Relationship between the urinary albumin-to-creatinine ratio and cardiovascular adverse outcomes in the Beijing community population: a prospective cohort study

Por: Liu · S. · Jia · J. · Huo · Y. · Fan · F. · Zhang · Y.
Objectives

To investigate the correlation between the urinary albumin-to-creatinine ratio (UACR) and adverse cardiovascular outcomes in the Beijing community population.

Design

Prospective cohort study.

Setting

Beijing, China, from May 2014 to December 2021.

Participants

Recruited from a survey conducted as part of an ongoing atherosclerosis cohort study in the communities of Gucheng and Pingguoyuan, Shijingshan District in Beijing, China. Excluded participants who already had a history of stroke or myocardial infarction at baseline. Finally, 3627 eligible participants were included in this analysis.

Exposure

The participants were divided into three groups on the basis of baseline UACR: the normal group (UACR

Primary and secondary outcome measures

The primary endpoint was a composite endpoint (major adverse cardiovascular event, MACE) of cardiovascular death, first acute myocardial infarction or first stroke, whereas secondary endpoints included cardiovascular death, first acute myocardial infarction, first stroke or all-cause death.

Results

The study included 3627 participants. According to the multivariable Cox model, compared with those in the normal group, the risks of MACE (HR=1.47; 95% CI 1.06 to 2.06; p=0.023), cardiovascular death (HR=3.03; 95% CI 1.56 to 5.88; p=0.001) and all-cause mortality (HR=1.91; 95% CI 1.23 to 2.97; p=0.004) were significantly greater in the microalbuminuria group. The risk of MACE (HR=3.65; 95% CI 2.14 to 6.23; p

Conclusions

This study indicates that an elevated UACR is a significant risk factor for adverse cardiovascular outcomes within the community population. This association remains consistent in individuals with low-grade albuminuria.

Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia

Por: Bussmann · B. M. · George · B. · Robinson · M. · Grist · J. · Sukumar · P. · Chinherende · E. · Sheerin · F. · Enzhil · V. · Rider · O. · Jones · B. · Sabharwal · A. · Herring · N.
Introduction

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.

Methods and analysis

RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.

Ethics and dissemination

This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.

Trial registration number

ISRCTN49861434.

Association between angiotensin receptor-neprilysin inhibitor use and clinical outcomes in patients with heart failure: a 1-year prospective cohort study from Jordan

Por: Odeh · R. S. · Abdel Jalil · M. · Qudah · M. A. · Al-Makhamreh · H. K. · Saleh · A. · Awwad · O.
Objectives

Heart failure (HF) is associated with complex symptoms and frequent hospitalisation that reduce patients’ quality of life (QoL). This study aims to assess the association between angiotensin receptor-neprilysin inhibitor (ARNI) use and changes in QoL and disease-related outcomes among patients with HF in Jordan.

Design

Prospective observational cohort study.

Setting and participants

The study was conducted among patients with HF attending the outpatient cardiology clinics at Jordan University Hospital, a tertiary care centre in Amman, Jordan. Patients either initiated on ARNI or receiving angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB) were included in the study at a 1:2 ratio. All participants were followed up for up to 1 year after recruitment. The study period was from 4 February 2024 to 29 May 2025.

Primary and secondary outcome measures

Data on QoL, New York Heart Association (NYHA) functional class and left ventricular ejection fraction (LVEF) were collected at baseline and after 3 months of treatment. Hospitalisation data were collected for the preceding year and the year following participants’ recruitment. Medication adherence and ARNI side effects were assessed after 3-month of follow-up period.

Results

A total of 227 patients with HF were included; 74 were initiated on ARNI, and 153 were receiving ACEIs/ARBs. At baseline, significantly lower QoL scores and LVEF were observed in the ARNI group compared with the ACEIs/ARBs group. After 3-month, the ARNI group showed improvements in all QoL scores, NYHA functional class and LVEF (p

Conclusions

ARNI use was associated with favourable QoL, NYHA class, and LVEF as well as lower hospitalisation rates among patients with HF in Jordan. The safety profile was consistent with previous studies.

Effectiveness of a co-adapted virtual discharge education app on disease knowledge and health behaviours in patients following heart attack: a multicentre, randomised controlled trial protocol in Sydney, Australia

Por: Zhang · L. · Shi · W. · Zhao · E. · Hyun · K. K. · Zecchin · R. · Gao · Y. · Brunorio · L. · Stanaway · F. · Ellis · T. · Redfern · J. · Clark · R. · Du · H. · Gallagher · R.
Introduction

Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.

Methods and analysis

This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.

Ethics and dissemination

The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.

Trial registration number

ACTRN12624000408583.

Left atrial appendage closure versus direct oral anticoagulants after pulmonary vein isolation for atrial fibrillation: protocol for a multicentre, prospective, randomised, non-inferiority trial (PROMOTE study)

Por: Shen · L. · Jiang · L. · Hao · Z. · Chu · H. · Wang · X. · Ning · Z. · Zhang · J. · Yang · B. · Xu · Y. · Fang · R. · Kong · L. · Zhang · X. · He · Q. · Zhang · Z. · Zhang · T. · Du · C. · Wu · Y. · Zhao · D. · Huang · H. · Ma · W. · Liang · Z. · Pan · X. · Wang · C. · Miao · Y. · Shen · L. · He · B.
Introduction

Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy.

Methods and analysis

The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality.

Ethics and dissemination

The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences.

Trial registration number

ChiCTR2000036538.

Development and validation of a machine learning model for prediction of 1-year mortality following ST-elevation myocardial infarction: a retrospective cohort study

Por: Sritharan · H. P. · Nguyen · H. · Ciofani · J. L. · Bhindi · R. · Allahwala · U. K.
Objectives

To develop a machine learning (ML)-based risk prediction model for 1-year mortality in ST-elevation myocardial infarction (STEMI) patients undergoing primary or rescue percutaneous coronary intervention.

Design

Patient data, including demographic, clinical, biochemical, imaging and procedural details, were extracted from electronic medical records. Data were split into training (80%) and test (20%) sets. Eight supervised learning algorithms were evaluated: least absolute shrinkage and selection operator, ridge, Elastic Net (EN, decision tree, support vector machine, random forest, AdaBoost and gradient boosting. Feature selection was performed sequentially with subsets of the top 5/10/15/20/25/30 features. Model hyperparameters were optimised using fivefold cross-validation with area under the curve (AUC) as the scoring metric.

Setting

Single, tertiary Australian centre.

Participants

We analysed data from 1863 consecutive STEMI patients treated at a tertiary Australian centre from July 2010 to December 2019.

Outcome measures

The primary outcome was 1-year all-cause mortality.

Results

The 1-year mortality rate was 13.6% (n=254) in our cohort. The EN model with five key features (parsimonious model) demonstrated superior performance, achieving an AUC of 0.821, which was comparable to the full 30-variable model (AUC 0.821). Advanced age, pre-hospital cardiac arrest and management with balloon angioplasty alone were identified as predictors of increased mortality risk, while family history of premature coronary disease and higher left ventricular ejection fraction were associated with improved survival. To facilitate clinical implementation, we developed a user-friendly web application for individualised risk assessment.

Conclusion

Our ML model accurately predicts 1-year mortality in STEMI patients using only five clinical variables. This tool offers improved accuracy and ease of use compared with existing risk stratification methods, potentially enhancing patient stratification and guiding treatment decisions in STEMI management.

Assessment of health-related quality of life and treatment satisfaction and their associated factors among older adults with heart failure: a prospective observational study in selected hospitals in Northwest Ethiopia

Por: Tarekegn · G. Y. · Dagnew · F. N. · Wondm · S. A. · Anberbr · S. S. · Tamene · F. B. · Tsega · S. S. · Asmare · Z. A. · Zeleke · T. K. · Dagnew · S. B. · Zerihun · T. E. · Kassaw · A. T. · Mussie · D. A. · Melese · T. B. · Moges · T. A.
Objectives

To assess health-related quality of life (HRQoL), treatment satisfaction and associated factors among older adults with acute heart failure in Northwest Ethiopia.

Design

Prospective, multicentre observational study.

Setting

Three tertiary hospitals in Northwest Ethiopia provide secondary and tertiary care services.

Participants

A total of 422 patients aged ≥60 years with a confirmed diagnosis of acute heart failure were consecutively enrolled between December 2024 and April 2025. Patients with unstable psychiatric conditions or advanced kidney disease were excluded.

Outcome measures

HRQoL was assessed using the WHO Quality of Life – Brief Version questionnaire, and treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Multiple linear regression identified factors associated with HRQoL and treatment satisfaction.

Results

95% of participants reported moderate HRQoL, and 3% reported poor HRQoL. Weight loss was positively associated with HRQoL (β=1.52; 95% CI 0.04 to 3.07; p=0.021), whereas asthma was negatively associated with HRQoL (β = –3.28; 95% CI 6.94 to 0.37; p=0.001). Regarding treatment satisfaction, 65% of patients were moderately satisfied, with notable concerns regarding medication safety and overall experience. Rural residents reported lower satisfaction than urban residents (β = –0.20; 95% CI 0.34 to 0.05; p=0.007). Patients with New York Heart Association (NYHA) class III had higher satisfaction (β=0.25; 95% CI 0.05 to 0.45; p=0.016). Effective hypertension management was linked to increased satisfaction (β=0.20; 95% CI 0.02 to 0.37; p=0.026), whereas coronary heart disease was associated with lower satisfaction (β = –0.40; 95% CI 0.64 to 0.88; p=0.012).

Conclusions

Among older adults with heart failure in Northwest Ethiopia, 98% reported moderate to low HRQoL. Asthma and polypharmacy negatively affected HRQoL, whereas weight loss was positively associated with HRQoL. An NYHA class III status and well-managed hypertension improved treatment satisfaction, whereas rural residency and coronary heart disease were associated with lower satisfaction. These findings underscore the need for targeted interventions to enhance outcomes and QoL in this vulnerable population.

Social determinants of health and risk of lower extremity amputation in patients with peripheral artery disease in Canada: protocol for a systematic review and meta-analysis

Por: Chowdhury · A. · Sheikh · F. · Azab · S. M. · de Souza · R. J. · Banfield · L. · Balakrishnan · N. · Anand · S. S.
Introduction

Peripheral artery disease (PAD) affected approximately 800 000 Canadians aged 25 years or older in 2015 and it poses a substantial risk of lower extremity amputation (LEA). While clinical risk factors for amputation are well-established, the impact of social determinants of health (SDoH) on amputation risk remains unclear, particularly in a Canadian context.

Objectives

This systematic review aims to: (1) synthesise evidence on the associations between multilevel SDoH domains and LEA (both major and/or minor) risk in Canadian PAD patients including intersectional effects of race and ethnicity with another SDoH domain, and (2) evaluate the statistical methodologies used in the researched literature to inform future study design and analysis approaches.

Methods and analysis

We will systematically search MEDLINE, Embase, EmCare, Global Health, Cumulative Index to Nursing and Allied Health Literature and Web of Science for studies examining SDoH and LEA in Canadian patients with PAD (including chronic limb-threatening ischaemia which is a severe form of PAD). Date limits for each database will be from inception through December 2025. SDoH will be categorised using a modified Healthy People 2030 SDoH framework under six domains: economic stability, education, food, neighbourhood and physical environment, healthcare system and community and social context. Two reviewers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third reviewer. Data will be extracted on study characteristics, SDoH measures, outcomes and statistical methods. Risk of bias will be assessed using RoB 2 for randomised trials, ROBINS-I for non-randomised studies of interventions and ROBINS-E for studies investigating exposures. A narrative synthesis, and where data permit, a Bayesian hierarchical meta-analysis using both effect size and contingency table approaches will be conducted. Statistical heterogeneity will be explored through subgroup analyses and meta-regression, examining study design, SDoH measurement approaches and population characteristics.

Ethics and dissemination

As a systematic review and meta-analysis, ethics approval is not required. For institutional oversight, we provide the contact of Dr Sonia Anand (Associate Vice-President, Global Health, McMaster University; anands@mcmaster.ca). Results will be reported following PRISMA guidelines and disseminated through a peer-reviewed publication.

PROSPERO registration number

CRD420251115759.

Evaluation of a pharmacist-led patient-self-testing model for warfarin management in patients undergoing mechanical heart valve replacement in China: a multicentre, open-label, randomised, controlled trial

Por: Wang · C. · Luo · J. · Zhou · X. · Guo · Y. · Cao · W. · Zhang · D. · Song · L. · Tan · S.
Objectives

Patient self-testing (PST) for warfarin management is well-established in developed countries but remains underused in developing regions. This study compared the safety and effectiveness of PST with usual care (UC) in China.

Design

A multicentre, open-label, randomised, controlled trial.

Setting

A total of five centres participated in this study, including one provincial tertiary hospital, two municipal tertiary hospitals and two primary hospitals.

Participants

Patients undergoing mechanical heart valve (MHV) replacement at five centres were prospectively enrolled. Patients were trained and stratified according to time on warfarin at enrolment and were randomly assigned to the PST or UC group.

Interventions

The PST group used a point-of-care testing device for at-home international normalised ratio (INR) monitoring with pharmacist-guided warfarin dosing, while the UC group attended outpatient clinics for INR monitoring and dosing.

Primary and secondary outcome measures

The primary outcome was the difference in time in therapeutic range (TTR). The secondary outcomes were incidences of major bleeding, thromboembolism and all-cause deaths in 12 months.

Results

From March 2021 to March 2023, a total of 556 patients were enrolled, with a mean age of 47.5 years, 45.1% being male. 342 were newly initiating warfarin therapy, while 214 had been on warfarin for over 6 months. Baseline characteristics were similar between the PST and UC groups. The PST group showed significantly higher TTR (67.2% vs 55.1%, p

Conclusions

A pharmacist-led PST intervention with ongoing education and counselling led to improved TTR and clinical outcomes in patients with MHV in China.

Trial registration number

China Clinical Trial Registry (ChiCTR2000038984).

Physical fitness and cognitive function: a cross-sectional study among adults in Qatar

Por: Alabdulrazzak · A. · Al-louzi · T. · Rahhal · M. O. · Albaloshi · A.-J. · Al-Emadi · R. · Al Mohannadi · M. · Abdulrahman · J. · Hasan Farooqui · H. · Pedersen · S. · Mahmood Al Saady · R.
Objective

This study aims to investigate the association between physical fitness and markers of cognitive function in adults aged 40 and above in Qatar.

Design

A cross-sectional study.

Setting

The Qatar Biobank, data of 1000 adults aged 40 and above.

Participants

A population of 1000 adults aged 40 years and older was included. Available data comprised measures of physical fitness including cardiorespiratory fitness, muscular strength, body composition and physical fitness capacity, as well as cognitive function assessed through tests of short-term visual memory and psychomotor coordination.

Primary and secondary outcomes

This paper investigated the physical fitness effect on cognitive functioning through short-term visual memory and psychomotor coordination testing. Logistic regression was used to measure the association between physical fitness and cognitive functioning tests.

Results

Our study showed that lower physical fitness capacity was significantly associated with lower psychomotor coordination in females (OR=1.57, p=0.040) and showed no significant association in males (OR=1.65, p=0.062). For short-term visual memory, the association was significant in females (OR=1.68, p=0.042) unlike in males (OR=1.58, p=0.062). Males with greater muscle strength were about half as likely to have lower psychomotor coordination (OR=0.48, p=0.04). In females, a higher body fat percentage was associated with poorer cognitive function, with each 1% increase in body fat being linked to 6% higher odds of low short-term visual memory (p=0.02) and low psychomotor coordination (p=0.006). Cardiorespiratory fitness showed no statistically significant association with short-term visual memory and psychomotor coordination level in either sex.

Conclusion

Our findings suggest that overall physical fitness capacity is associated with better cognitive function in Qatari adults. The relationship between specific fitness measures and cognitive function varied by sex, with muscle strength having a stronger effect for males and body composition for females. These results highlight the potential importance of maintaining physical fitness for cognitive health in adulthood.

Use of SGLT2 inhibitors and GLP-1 receptor agonists in patients with ischaemic heart disease and type 2 diabetes in Swedish primary care: a cross-sectional analysis of regional primary care registry data (QregPV)

Por: Andersson · T. · Bager · J.-E. · Hellgren · M. · Aberg · M. · Mourtzinis · G.
Objectives

To assess the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA) among patients with coexisting ischaemic heart disease (IHD) and type 2 diabetes (T2D) in primary care, in relation to European guidelines.

Design

Cross-sectional observational study.

Setting

209 primary healthcare centres in Region Västra Götaland, Sweden (population 1.8 million in 2023).

Participants

14 414 patients with registered prevalent diagnoses of coexisting IHD and T2D, September 2023, in QregPV, the regional primary care quality of care register in Region Västra Götaland. Data on dispensed drugs were retrieved from the regional prescribed drug register, Digitalis.

Primary and secondary outcome measures

The primary outcome was the proportion of patients with dispensed SGLT2i or GLP-1 RA in relation to sex, age and primary healthcare centres (including private vs public ownership). The secondary outcome was estimated additional prescription costs.

Results

SGLT2i was dispensed to 37.2%, less often to women (adjusted OR (aOR) 0.64 (95% CI 0.59 to 0.70)). GLP-1 RA was dispensed to 10.0%, with no sex difference (aOR 1.04 (95% CI 0.92 to 1.18)). Use of SGLT2i and GLP-1 RA declined with age (p

Conclusion

SGLT2i and GLP-1 RA were underutilised in patients with coexisting IHD and T2D. The sex disparity in SGLT2i use warrants attention, as does the substantial variation between primary healthcare centres and the challenges of implementing costly cardioprotective therapies.

Device-assessed sleep health among older patients with heart failure: a cross-sectional study using actigraphy

Por: Krishnan · S. · Taylor · S. · Edwardson · C. L. · Rowlands · A. V. · Squire · I. B. · Sze · S.
Objective

Poor sleep is common among patients with heart failure (HF) and is associated with adverse cardiovascular outcomes. The utility of actigraphy in sleep assessment, especially among older adults, remains underexplored. This study aimed to assess sleep health among older adults with HF using actigraphy and explore associations between sleep parameters and cardiac biomarkers, functional performance and quality of life (QoL).

Design

A cross-sectional study.

Setting

The study was conducted at an outpatient HF clinic within a tertiary cardiology service in a National Health Service hospital in the UK between March and October 2023.

Participants

A total of 150 older adults aged ≥65 years with a diagnosis of HF were enrolled.

Methods

Participants were given a wrist-accelerometer to wear for 7 days. On Day 0, patients completed a 4-metre walk test (4MWT), handgrip strength test (HGST), Timed Up and Go test (TUGT), Barthel Index (BI), Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and frailty assessment (Clinical Frailty Scale, CFS). Subsequently, they were fitted with an accelerometer, with the device configured to start recording the following day (Day 1). Sleep outcomes were calculated after a 7-day wear period and averaged across valid nights (minimum 3 nights of recording, noon-to-noon with ≥16 hours wear-time). Sleep parameters studied include average sleep efficiency, sleep period time window, sleep duration, sleep onset and wake up time, wake after sleep onset (WASO), sleep interruptions and Sleep Regularity Index (SRI). Inefficient sleep was defined as sleep efficiency

Outcome measures

The primary outcome measure was sleep efficiency; all other sleep parameters were classified as secondary or exploratory outcomes.

Results

Accelerometry data from 145 participants were analysed; 42% had inefficient sleep based on average sleep efficiency across valid nights. These patients had significantly higher plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (p=0.044). No statistically significant difference was noted in 4MWT, HGST, TUGT, BI, KCCQ-12 and CFS between patients with sleep efficiency

Conclusions

Older adults with HF who had inefficient sleep had significantly higher NT-proBNP levels. Lower sleep efficiency was associated with higher functional dependence and frailty. Sleep irregularity was linked to HF symptom load, frailty, functional performance and QoL, while sleep fragmentation was associated with impaired gait speed.

Effectiveness and cost utility of a nurse-led Heart Failure Follow-Up Program: a quasi-experimental multicentre study protocol in three Spanish public hospitals

Por: Mesa Rico · R. · Gomez-Garcia Olias · S. · Carbonell-Munoz · P. · Codes-Perujo · M. · Lloreda-Palma · L. · Atienza-Carrasco · J. · Bravo-Marques · R. · Canca-Sanchez · J. C. · Romero · A. · Jodar-Sanchez · F.
Introduction

This study aims to evaluate a structured nurse-led follow-up programme coordinated by an advanced practice nurse (APN) as an alternative to conventional postdischarge care for patients with heart failure (HF). The main objective is to assess the clinical effectiveness and economic efficiency of the programme using quality-adjusted life years and healthcare costs related to resource use as outcome measures.

Methods and analysis

A quasiexperimental multicentre study will be conducted including an intervention group and a comparison group of patients discharged with HF from three public hospitals in the province of Málaga, Spain. The intervention group will be followed by an APN using a structured follow-up model, while the comparison group will receive standard care. Sociodemographic, clinical, quality of life, self-care, therapeutic adherence and healthcare resource utilisation data will be collected. The economic evaluation will be conducted from the perspective of the public healthcare system through a cost-utility analysis.

Ethics and dissemination

The study protocol has been approved by the corresponding Research Ethics Committee. All participants will provide written informed consent prior to inclusion. The results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.

Factors influencing the decision to accept or decline aortic valve replacement for asymptomatic aortic stenosis: a nested longitudinal qualitative substudy of the EASY-AS randomised trial

Por: Allmark · P. · Taylor · B. · Tod · A. M. · Ryan · T. · Dweck · M. · McCann · G. P. · Singh · A.
Objective

To examine how patients and family members decide whether to accept a highly invasive intervention (aortic valve replacement (AVR)) when their condition (aortic stenosis (AS)) is asymptomatic and its course uncertain.

Design

Nested, longitudinal, qualitative substudy of an ongoing randomised controlled trial (RCT) (NCT04204915) testing early intervention (EI) versus watchful waiting (WW) in patients with asymptomatic severe AS.

Setting

Six select UK sites of the RCT.

Participants

Select participants of the RCT, their next-of-kin and some who declined RCT participation.

Results

73 interviews were conducted, with 41 participants.

Few knew much about AS before diagnosis. Uncertainty and the need for reliable information regarding symptoms and progress was a significant problem.

While some expressed unease at a major intervention for an asymptomatic condition, there were no outright objections to the idea.

Those who declined participation in the RCT did so for personal reasons, for example, their home circumstances did not permit the required period of recovery or they felt too old to risk intervention.

Reasons for accepting early intervention included the belief that the condition was serious and likely to deteriorate, and so better to have the intervention before such deterioration, as well as avoiding long waiting lists. Trusting clinicians’ judgement played a part in some decisions. Patients also wanted choice in the type of intervention received.

The longitudinal interviews (n=32) showed satisfaction in the early intervention group despite some problems in the the early recovery phase, especially for those undergoing surgical AVR.

Conclusions

Where evidence supports major intervention for an asymptomatic condition, patients are likely to accept the offer, although personal circumstances play an important role in decision-making. Where a condition is not well known to the public, such as AS, patients rely on clinicians and other resources to help decide. Liaison with patient groups in developing shared decision-making resources may help with complex decisions.

Trial registration number

NCT04204915

Risk prediction models for detecting a new diagnosis of heart failure within 5 years in the community: a systematic review

Por: Thaitirarot · C. · Sze · S. · Jones · N. · Barker · J. · Chan · A. · Hobbs · F. D. R. · Taylor · K. S. · Taylor · C. J.
Objectives

Earlier heart failure (HF) diagnosis in the community could allow timely treatment initiation and prevent unnecessary hospitalisation, but identifying those at risk remains challenging. We aimed to summarise the performance of risk prediction models for a new diagnosis of HF.

Design

Systematic review of multivariable incident HF risk prediction models in the community setting.

Data sources

MEDLINE and Embase were searched from inception to 9 November 2023.

Eligibility criteria

Observational, community-based studies reporting prediction model performance for incident HF within a 5-year time horizon.

Data extraction and synthesis

Two reviewers independently screened and extracted data. Where possible, C-statistics (or area under the receiver operating characteristic curve) with 95% CIs were extracted. Risk of bias was assessed using the Prediction model Risk Of Bias ASsessment Tool and certainty of evidence by the Grading of Recommendations, Assessment, Development and Evaluation.

Results

Eighteen studies described 45 prediction models, 27 used traditional statistical methods and 18 applied machine learning. Most (39/45) demonstrated acceptable discrimination (C-statistic >0.70). Overall, C-statistics ranged from 0.675 to 0.954, typically with narrow 95% CIs. External validation was performed for 31 models, but only two—the modified PCP-HF models for white men and women—were validated in three cohorts, the highest among all the models. Exploratory random-effects meta-analysis of these models showed pooled C-statistics of 0.82 (95% CI 0.82 to 0.82) for men and 0.85 (95% CI 0.82 to 0.88) for women, indicating excellent discrimination but more heterogenous performance among women. Model performance was at high risk of bias due to unreported or inappropriate handling of missing data, and the certainty of evidence was very low.

Conclusion

Risk prediction models for a new diagnosis of HF in the community performed well, but were at high risk of bias and lacked external validation. Future model development requires appropriate data sources, robust handling of missing data, external validation and clinical testing to assess their impact on earlier HF diagnosis and outcomes.

PROSPERO registration number

CRD42022347120.

Screening for hypertension in the inpatient environment (SHINE): a prospective diagnostic accuracy study among adult hospital patients

Por: Armitage · L. C. · Roman · C. · Lawson · B. K. · Mahdi · A. · Biggs · C. · Young · L. · Edmundson · H. · Fanshawe · T. · Tarassenko · L. · Farmer · A. · Watkinson · P. J.
Background

Hypertension is the leading risk factor for death globally. Undiagnosed hypertension is common, but the incidence in hospitalised patients is unclear. There are calls for universal facility-based screening for hypertension among all attending patients. The hospital inpatient setting, where blood pressure (BP) is measured routinely and repeatedly, presents an ideal opportunity. However, international hypertension guidelines do not include inpatient BP thresholds for diagnostic or treatment purposes. We investigated the performance of current UK community BP thresholds for diagnosing hypertension in the hospital setting.

Objectives

Investigate the diagnostic performance of the current UK ambulatory BP diagnostic thresholds for systolic and diastolic hypertension in the hospital setting against the reference test of community-based ambulatory BP monitoring (ABPM).

Design

A prospective diagnostic accuracy study.

Setting

Hospital inpatients admitted to three UK centres were approached. Follow-up ABPM was delivered in the community.

Participants

Eligible patients were aged between 18 and 80 years, with no prior diagnosis of, or prescription for hypertension, and whose mean cumulative daytime BP was 120 mm Hg to 179 mm Hg systolic and ≤109 mm Hg diastolic from the 24th hour of their hospital admission.

Interventions

Participants received 24-hour ABPM 4–26 weeks post-discharge, as the reference test for hypertension, with UK diagnostic thresholds of an average daytime BP of ≥135 mm Hg systolic and ≥85 mm Hg diastolic applied. Participants found to be severely hypertensive at the ABPM fitting appointment were also considered reference-test positive but did not proceed with ABPM.

Primary and secondary outcome measures

The diagnostic performance of a mean daytime in-hospital BP of ≥135 mm Hg systolic or ≥85 mm Hg diastolic (index test) for the prediction of hypertension diagnosed on ABPM (reference test) was assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as primary outcome measures. Additionally, we explored the accuracy of a range of alternative in-hospital systolic and diastolic BP thresholds against the same reference test.

Results

351 participants were enrolled and 206 completed the study protocol. The average age of the 206 participants was 53 years, 55% were male, and 91 (44%) had daytime community hypertension on ABPM reference testing. Of 107 participants with raised in-hospital daytime BP, 59 (55%) had daytime community hypertension. When assessing the performance of the index test for detecting daytime community hypertension, sensitivity was 65% (59/91, 54% to 75%) and specificity was 58% (67/115, 49% to 67%). The PPV was 55% (59/107, 45% to 65%) and NPV was 68% (67/99, 58% to 77%), respectively. A further 45/206 participants (23%) had night-time community hypertension when assessed using European diagnostic thresholds for nocturnal hypertension (120 mm Hg systolic or 70 mm Hg diastolic), while 25/107 of those with raised in-hospital daytime BP (23%) had night-time community hypertension. When assessing the performance of the index test for detecting either day or night-time community hypertension, sensitivity was 62% (84/135, 53% to 70%) and specificity was 68% (48/71, 55% to 78%). The PPV was 79% (84/107, 70% to 86%) and NPV was 48% (48/99, 38% to 59%).

Conclusions

Undiagnosed hypertension is common in hospitalised patients, particularly those with raised in-hospital BP. While in-hospital BP alone is an imperfect predictor and should not be used as a stand-alone diagnostic test, this could serve as a trigger for further assessment of BP in the community after discharge.

Trial registration number

The study protocol was registered with the ISCTRN Registry (ISRCTN80586284).

Rationale and design of the REMECHOQUE multicentre registry protocol: evaluating therapeutic trends in cardiogenic shock

Introduction

Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.

Methods and analysis

The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.

Ethics and dissemination

Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.

Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (SPEEDY): study protocol for a cluster randomised controlled trial with included health economic and process evaluations

Por: Shaw · L. · Allen · M. · Day · J. · Ford · G. A. · James · M. · McClelland · G. · McMeekin · P. · Mossop · H. · Pope · C. J. · Simmonds · R. L. · White · P. · Wilson · N. · Price · C. I.
Background

Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.

Methods and analysis

This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.

Ethics and dissemination

This study has ethical, Health Research Authority and participating NHS Trust approvals.

Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.

Trial registration number

ISRCTN77453332.

Exploring the mechanisms of yoga-based cardiac rehabilitation in heart failure via assessment of endothelial function, genomics and arterial health (Yoga-EndOmics): a study protocol

Por: Shetty · V. V. · Patil · L. R. · Patil · S. G. · Aithal · K. · Oli · A. K. · Yenagi · V. A. · Kaulgud · R. S. · Dharne · M. · Chandra Sekaran · A. M. · Prabhakaran · D.
Introduction

Heart failure (HF) remains a major global health challenge, particularly in low-resource settings where access to comprehensive cardiac rehabilitation (CR) is limited. Yoga, a culturally contextualised mind-body intervention, holds promise as an adjunctive therapy in CR. The Yoga-EndOmics study aims to evaluate the effects of Yoga-based cardiac rehabilitation (Yoga-CaRe) on gene expression, endothelial function, vascular biomarkers and clinical outcomes in systolic HF, providing mechanistic insights into its potential integration into conventional cardiac rehabilitation.

Methods and analysis

This is a prospective, randomised, open-label, blinded-endpoint (PROBE) mechanistic trial enrolling 78 patients with HF with reduced ejection fraction (HFrEF). Participants will be randomised in a 1:1 ratio to receive either a structured Yoga-CaRe intervention or enhanced standard care for 3 months. The Yoga-CaRe group will attend 20 supervised sessions with guided home practice involving tailored asanas, pranayama and meditation. Primary outcomes are changes in endothelial-dependent flow-mediated dilation (FMD) and functional exercise capacity at 3 months. Secondary outcomes include changes in arterial compliance and stiffness, circulating biomarkers of endothelial dysfunction, oxidative stress and inflammation, and immediate changes in global gene expression profiles in peripheral blood mononuclear cells following the Yoga-CaRe intervention. Data will be analysed using analysis of covariance (ANCOVA) for between-group comparisons and significant analysis of microarray (SAM) for global gene expression profiles.

Ethics and dissemination

The study has received ethical clearance from the Institutional Ethics Committee of the SDM College of Medical Sciences and Hospital, India (SDMIEC/2025/1072) and is registered with the Clinical Trials Registry of India. Findings will be disseminated through peer-reviewed journals, scientific conferences and stakeholder engagement platforms to inform future integrative strategies in HF management.

Trial registration number

CTRI/2023/12/060758

Patients lived experiences and coping mechanisms following mitral valve replacement at the National Cardiac Institute in Tanzania: a qualitative study

Por: Kisangija · J. P. · Buluba · S. E. · Ndile · M. L.
Objective

To qualitatively explore patients’ lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.

Design

A descriptive qualitative study using in-depth interviews and thematic analysis.

Setting

The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.

Participants

17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.

Main outcome measures

Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.

Results

Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.

Conclusion

Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.

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