Polypill Strategy for Heart Failure With Reduced Ejection Fraction
Summary
Heart failure with a reduced ejection fraction (HFrEF) represents a significant public health burden in the United States, with a growing prevalence particularly among African Americans and Hispanic Americans and individuals of low socioeconomic status (SES). Although effective therapies exist, gaps in their uptake contribute substantially to the excess burden of heart failure. The "polypill" is an inexpensive once daily pill containing three agents proven to improve morbidity and mortality in heart failure and represents potential strategy for increasing the utilization of proven HF therapies. The proposed study is a pragmatic, single-center, randomized trial to test the feasibility and effectiveness of a polypill-based strategy for the treatment of HFrEF in a low-income, racially diverse population.
Timeline
- Start
- 2021-11-15
- Primary completion
- 2025-10-15
- Completion
- 2025-10-31
Publications
- Pandey A, Keshvani N, Rizvi SK, Khashami F, Yaros K, Usman MS, Segar MW, Jain AK, Coellar JD, Bustillo-Rubio M, Cox ZL, Thibodeau JT, Ahn C, Gupta DK, Chandra A, Drazner MH, Hussain MT, Zaha VG, Wang TJ. Polypill for heart failure with reduced ejection fraction: the POLY-HF randomized trial. Nat Med. 2026 Jul 2. doi: 10.1038/s41591-026-04504-5. Online ahead of print.
- Keshvani N, Coellar JD, Patel MJ, Bustillo-Rubio M, Ruiz E, Gracia L, Agarwal A, Wang TJ, Kitzman H, Pandey A. Patient Perspectives on a Polypill Strategy for Heart Failure With Reduced Ejection Fraction: A Convergent-Parallel Mixed Methods Study Embedded in a Randomized Clinical Trial. Circ Popul Health Outcomes. 2026 Feb;19(2):e012834. doi: 10.1161/CIRCOUTCOMES.125.012834. Epub 2025 Nov 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 25 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 50 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 100 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 150 mg | Oral |
| Subject | Spironolactone | Small molecule | 12.5 mg | Oral |