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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.

Assessment of Diastolic Function during the transitional period and infancy using Serial Echocardiography in a tertiary neonatal unit (DiFuSE): a longitudinal prospective observational study protocol

Por: Stapleton · I. · Bussmann · N. · Finn · D. · Livingstone · V. · Dempsey · E.
Introduction

There are structural and functional modifications that occur to the neonatal heart immediately after birth. While a number of studies recently have assessed cardiac function in the newborn, there is a dearth of data on diastolic function in the neonatal period during transition and into infancy. The objective of this study is to assess diastolic function in a large cohort of infants to provide normative reference values and to assess the influence of predefined maternal and infant characteristics.

Methods and analysis

This is a single-centre observational study of babies born at 35 weeks of gestation and above, involving echocardiography in the first 2 DOL and longitudinal follow-up of these infants up to 18 months of age. The echocardiographic measurements to assess diastolic function used in this study include conventional echo measures, novel echo measures using tissue Doppler imaging and deformation measures using 2D speckle tracking echocardiography.

Ethics and dissemination

The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The findings from this study will be disseminated in peer-reviewed journals and during scientific conferences.

Trial registration number

NCT06200519.

What motivates GPs to vaccinate against influenza? Protocol for a mixed-methods study

Por: Bussmann · A. · Plath · E. · Minor · M. · Meyer · A. C. · Hagemann · C. · Damm · O. · Wasem · J. · Speckemeier · C.
Introduction

In Germany, influenza vaccination rates in at-risk groups are well below the 75% coverage recommended by the WHO. Although it has been shown that general practitioners (GPs) can play a key role in increasing their patients’ willingness to be vaccinated, this potential does not seem to have been fully used. This study aims to uncover factors that motivate GPs to vaccinate their patients against influenza, investigate the role of financial incentives in achieving higher vaccination rates and determine how the daily practice of GPs can be made more vaccination friendly.

Methods and analysis

A mixed-methods approach is employed to reach the research aims. Literature reviews will be conducted to identify factors that motivate GPs to vaccinate against influenza and to identify studies in which preferences are elicited. This is followed by semistructured interviews with GPs (n=6–10). The scoping reviews and interviews serve as a basis for the development of a quantitative survey directed at GPs which includes a discrete choice experiment. The quantitative survey will be sent to a total of 3760 GPs.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki. A positive vote has been received from the Ethics Committee of the Medical Association North Rhine (2024259). Study participants will only be included in the study after being given informed consent. Manuscripts will be prepared for the scoping review on motivating factors and after completion of the quantitative survey, which will be submitted to peer-reviewed journals. Interim results and final results of the project will be presented at conferences.

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