Heart Failure Clinical Trial
Protocol: STUDY00004802
Full Title
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%)
Description
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.

Technical Description

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: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
-Adults ages 40+.
-Diagnosed with heart failure (class II-IV).
Age Group: Adults
Principal Investigator: JOSEPH IZZO
ClinicalTrials.gov: Open Study
Contact(s)
KELLEY CAROZZOLO (Bilson)
kjc28@buffalo.edu
+1 716-898-5653
Want to Learn More?
Enrollment Update

Due to COVID-19, new enrollment in research studies will be greatly limited. If you are interested in a study, there may be a longer waiting period to receive a response to your inquiry. View the guidance for research participants for additional information.

Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.