A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction gt;40% (LVEF gt; 40%)
This study enrolls adults with a common type of heart failure (called “preserved ejection fraction” or HFpEF) that has no proven treatment and is often the result of poorly controlled high blood pressure. The purpose of this study is to learn if the new investigational drug finerenone improves outcomes and is safe in patients with HFpEF.
In this study, participants will continue their regular medications for heart failure except spironolactone, which has similarities to finerenone. Assignment of patients to different doses of the active drug or to a placebo is random (like flipping a coin). A placebo is an inactive substance formulated to look like the active drug that allows better comparison of the active drug’s effects. It is expected that you will visit our clinic 7 times in the first year and 3 times in the following years. You will also participate in follow-up phone calls. The study takes place in the Clinical Research area at ECMC in Buffalo, NY.
To demonstrate the superiority of finerenone to placebo in reducing the rate of the composite CV endpoint. To assess the safety and tolerability of finerenone.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
-Adults ages 40+.
-Diagnosed with heart failure (class II-IV).
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