Current Heart Failure

Heart Failure, Kidney Disease

Location(s): Rovia St. Augustine (ECIR Site)

Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Combining balcinrenone with Dapagliflozin is experimental, which means it is not approved by any health authority such as the United States Food and Drug Administration (FDA). Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Heart Failure

Location(s): Rovia Jacksonville – University (ECIR Site), Rovia Jefferson City (ECIR Site), Rovia St. Augustine (ECIR Site)

A Phase III double-blind, randomized, parallel-group superiority trial to evaluate efficacy and safety of the combined use oforal BI 690517 and empagliflozin compared with placebo andempagliflozin in participants with symptomatic heart failure (HF: NYHAII-IV) and left ventricular ejection fraction (LVEF) ≥40%.

The purpose of this clinical research trial is to look at the effectiveness, safety, and tolerance of combining the investigational trial drug called BI 690517 with empagliflozin (empa) in participants diagnosed with heart failure (HF). Empagliflozin is approved by the FDA for the treatment of heart failure.

In this trial, the investigational new treatment option BI 690517 is compared with a treatment with empa and placebo. You have a 50% chance (much like flipping a coin) of getting BI 690517 with empa, or empa and placebo. Please be aware that you may receive placebo that looks like the trial drug (BI 690517) but does not contain any medicine.

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