drugset / Trial / NCT04633005

Polypill Strategy for Heart Failure With Reduced Ejection Fraction

NCT04633005

Phase 2 Completed 212 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications