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What are the exercise barriers, facilitators and preferences of community-dwelling older adults with heart failure with preserved ejection fraction? A qualitative best fit framework analysis

Por: Forsyth · F. · Hartley · P. · Mant · J. · Rowbotham · S. · Sharpley · J. · Wood · A. · Deaton · C.
Objectives

To establish, through patient and public involvement (PPI) events, the exercise barriers, facilitators and preferences of people with heart failure with preserved ejection fraction (HFpEF).

Design

Qualitative ‘best fit’ framework analysis was used to analyse field notes and transcripts collected during three patient and public involvement meetings and three workshops. The best fit framework was based on the COM-B model of behaviour change, which has identified that Capability, Opportunity and Motivation components are essential for Behaviour change. The Consolidated criteria for Reporting Qualitative research checklist was used to structure the report.

Setting and participants: Community dwelling older adults with HFpEF.

Results

24 people with HFpEF (n=16 female, 66%), 2 spouses and 2 people with chronic conditions participated in the PPI meetings and workshops. Multiple exercise-related capability (negative symptoms, functional ability, resilience and self-efficacy and knowledge and skill); opportunity (appealing components, optimal conditions, adequate support); and motivation factors (well-being, physical gains, goal achievement, sense of enjoyment) were identified as essential to facilitating change in exercise behaviours in people with HFpEF.

Conclusions

This study provides insight into capability, opportunity and motivation conditions that people with HFpEF feel are necessary to enable them to engage in exercise-related behaviour change. This work extends previous post hoc work by moving beyond identification of broad influencers that may enable or impede exercise intervention engagement, to identify intervention conditions necessary to affect change.

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

Por: Marques · T. · Forsyth · C. · Barreira · F. · Lombas · C. · Blum de Oliveira · B. · Laserna · M. · Molina · I. · Bangher · M. d. C. · Javier Fernandez · R. · Lloveras · S. · Fernandez · M. L. · Scapellato · P. · Patterson · P. · Garcia · W. · Ortiz · L. · Schijman · A. · Moreira · O. C.
Introduction

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

Methods and analysis

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

Ethics and dissemination

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

Trial registration number

NCT04897516.

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