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Rationale, Design, and Baseline Characteristics of the Polypill for Heart Failure With Reduced Ejection Fraction
Neil Keshvani1, Syed K Rizvi2, Fatemeh Khashami3
1Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas; Baylor Scott and White Research Institute, Dallas, TX and Baylor Scott and White The Heart Hospital, Plano, Texas.
Journal of Cardiac Failure
|November 2, 2025
Summary
The POLY-HF trial tested a polypill for heart failure with reduced ejection fraction (HFrEF) in a diverse, vulnerable population. Results will offer key insights into polypill effectiveness for underrepresented groups.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) has proven efficacy, yet real-world utilization remains suboptimal.
- Polypill strategies, successful in preventing atherosclerotic conditions, have not been extensively studied in heart failure management.
Purpose of the Study:
- To evaluate the effectiveness of a polypill strategy compared to usual care for patients with HFrEF not on target GDMT.
- To assess the impact of the polypill on left ventricular ejection fraction (LVEF), clinical outcomes, quality of life, and medication adherence.
Main Methods:
- The POLY-HF trial was a two-center, open-label randomized controlled trial (RCT) involving adults with HFrEF (LVEF ≤ 40%).
- Participants were randomized to receive a once-daily polypill (metoprolol succinate, spironolactone, empagliflozin) or usual care with individual GDMTs.
- The primary endpoint was LVEF at 6 months assessed by cardiac MRI; secondary endpoints included a composite win-ratio endpoint, quality of life, adherence via therapeutic drug monitoring, and NT-proBNP levels.
Main Results:
- The study enrolled 212 participants (108 polypill, 104 usual care) with a median age of 54 years.
- The population was diverse, with 54% self-reported Black race and 33% Hispanic ethnicity, and a high burden of socioeconomic vulnerability (68% uninsured or reliant on county programs).
- Participants presented with advanced HFrEF (median LVEF 25%), elevated NT-proBNP (958 pg/mL), and a history of recent HF hospitalization (85%).
Conclusions:
- The POLY-HF trial successfully enrolled a diverse patient population with HFrEF characterized by low socioeconomic status and suboptimal medication adherence.
- This trial is poised to deliver the first randomized evidence on polypill efficacy for both biologic and clinical outcomes in HFrEF, particularly within underrepresented populations.
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