Rationale, Design, and Baseline Characteristics of the Polypill for Heart Failure With Reduced Ejection Fraction (POLY-HF) Trial
Abstract
Background: Despite the efficacy of guideline-directed medical therapy (GDMT) for heart failure (HF) with reduced ejection fraction (HFrEF), real-world utilization remains suboptimal. Polypill strategies have been trialed for the prevention of atherosclerotic conditions but not in HF.
Methods: The Polypill for Heart Failure (POLY-HF) trial was a 2-center, open-label randomized clinical trial conducted within a safety-net health care system and at a university hospital in Dallas, Texas (NCT04633005). Eligible participants were adults with HFrEF (left ventricular ejection fraction [LVEF] ≤40%) not receiving target dose GDMT. Participants were randomized 1:1 to once-daily overencapsulated polypill with multiple dose formulations (metoprolol succinate 25/50/100/150 mg, spironolactone 12.5 mg, empagliflozin 10 mg) vs enhanced usual care with individual GDMTs coordinated with outpatient cardiology/primary care. The primary endpoint was LVEF at 6 months adjusted for baseline, assessed by cardiac magnetic resonance imaging, and the secondary endpoints included a hierarchical composite win-ratio-based endpoint and changes in quality of life, adherence assessed by therapeutic drug monitoring, and N-terminal pro-brain natriuretic peptide (NT-proBNP).
Results: The study enrolled 212 participants (108 polypill, 104 usual care). The median age of the study population was 54 years, with 54% of participants of self-reported Black race and 33% of self-reported Hispanic ethnicity.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 212 participants or records.
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