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

ABSTRACT:

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. Participan

SUBMITTER: Agarwal A 

PROVIDER: S-EPMC12265811 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature