Polypill Strategy for Heart Failure With Reduced Ejection Fraction

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

Inclusion Criteria:

• Adults age > = 18 years

• HF with left ventricular ejection fraction <= 40% within 3 months of screening who are not on optimal guideline directed medical therapy

• New York Heart Association class II, III, or IV symptoms

Exclusion Criteria:

• Age < 18

• Systolic blood pressure < 120 mm Hg at enrollment

• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified

• MDRD formula

• Serum potassium > 5.0 mEq/L

• Current need for inotropes

• Cardiac index < 2.2 L/min/m2

• History of revascularization within 30 days or plan for revascularization

• History of type 1 diabetes mellitus

• History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i)

• Contraindication to receive any of the components of the polypill

• Pregnancy

• < 12 month expected survival

• Inability to provide written informed consent

• Persistent or permanent atrial fibrillation who may not have optimal MRI imaging

• Extreme obesity (BMI > 45 kg/m2)

• ICD/PAcemaker devices that are incompatible with MRI