Polypill strategy for the evidence-based management of heart failure with reduced ejection fraction in an underserved patient population - Heart failure poses a major public health challenge in the United States, with a growing prevalence. An expanding number of medications have been shown to improve survival in patients with heart failure with reduced ejection fraction (HFrEF). The list of guideline-directed medical therapies (GDMT) includes beta-blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, and mineralocorticoid receptor antagonists. When used in combination, these medications reduce all-cause mortality by > 50%. Nonetheless, fewer than 25% of eligible patients receive 3 or more of these medications, at any dose, with particularly low rates of utilization among low SES individuals. The polypill refers to a fixed-dose combination of medications in a single pill, aimed at reducing pill burden and improving adherence. The polypill strategy offers a means by which therapy with multiple medications can be conveniently initiated at an early stage of disease, increasing the overall therapeutic benefit accrued over time. This is particularly relevant in settings where patients experience barriers to care due to high costs, frequent lab tests, and need for multiple follow up visits. We propose a single-center, pragmatic trial of a polypill-based strategy for the treatment of HFrEF in a low-income, racially-diverse population. We will enroll 175 adults with HFrEF (left ventricular ejection fraction [LVEF] < 40%) receiving care at Parkland Hospital who are not on optimal, target dose of guideline-directed medical therapy at a large county hospital in Dallas, TX. Participants will be randomized to receiving a polypill or usual care. The primary endpoint of the study is the change in LVEF, and the key secondary outcome will be change in circulating NT-proBNP levels, quality-of-life, six minute walk distance, and the adherence to guideline directed medical therapy at 12 months. We hypothesize that use of a polypill-based strategy in HFrEF will be feasible and lead to improved left ventricular systolic function, NT-proBNP levels, quality of life, and adherence to target dose guideline directed medical therapy compared with usual care.
