Polypill for heart failure with reduced ejection fraction: the POLY-HF randomized trial.

Summary

In an open-label randomized trial of 212 patients with HFrEF, a once-daily polypill improved LVEF by 3.3 percentage points at 6 months versus enhanced usual care and reduced HF hospitalizations/ED visits by 60%. Pharmacologic adherence was significantly higher with the polypill, and tolerability was favorable.

Key Findings

• Primary endpoint met: between-group LVEF difference +3.3 percentage points by cardiac MRI at 6 months (95% CI 0.2–6.4; P=0.039).
• HF hospitalizations/ED visits reduced by 60% with polypill (adjusted rate ratio 0.40; 95% CI 0.18–0.88; P=0.024).
• Higher pharmacologic adherence with polypill (79% vs 54%; P=0.001) and fewer adverse events than enhanced usual care.

Clinical Implications

A fixed-dose HFrEF polypill could streamline initiation and titration, improve adherence, and reduce acute care use. Health systems may consider polypill programs alongside renin–angiotensin inhibition, especially in underserved populations.

Limitations

• Open-label, two-center design limits blinding and generalizability.
• Short-term (6-month) primary endpoint; not powered for mortality.

Future Directions

Larger, multicenter pragmatic and cost-effectiveness trials with longer follow-up to assess mortality, quality of life, and scalability across diverse health systems.