Heart failure with reduced ejection fraction polypill implementation strategy in Sri Lanka: design and protocol of a pilot type I hybrid randomised clinical trial

作者：Anubha Agarwal, Asita de Silva, Mansi Agarwal, Saumiyah Ajanthan, Anuradha Dahanayaka, Rupasvi Dhurjati, Chanaka Fernando, Gamini Galappatthy, Charles W. Goss, Adam Hively, Pathiyil B Jayagopal, P.P. Mohanan, Anushka Patel, Dorairaj Prabhakaran, M. B. F. Rahuman, Anthony Rodgers, Karl C. Roberts, Hyndavi Salwa, Mark D. Huffman, Abdul Salam · 发表于：BMJ Open · 年份：2025 · DOI：10.1136/bmjopen-2025-100952 · 被引用次数：2 · 研究领域：Medication Adherence and Compliance、Heart Failure Treatment and Management、Advanced Causal Inference Techniques

INTRODUCTION: Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility. METHODS AND ANALYSIS: This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes. ETHICS AND DISSEMINATION: The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the Nati...