A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

This study is looking for adults aged 18 or older who have been diagnosed with ongoing heart failure for at least three months. A key requirement is that your heart's main pumping chamber (the left ventricle) needs to be working less effectively than normal, specifically described as a 'reduced ejection fraction' of under 40%. You should also be experiencing symptoms of heart failure, ranging from mild to more severe.

To be considered, your doctors must also be managing your heart failure with the best available standard treatments, following current guidelines. There will be specific blood tests done to check certain markers related to heart failure.

However, you won't be able to join if you've recently been taking or need to take certain heart medicines called MRAs (like spironolactone or eplerenone) or other specific water tablets (like amiloride) within the last two weeks. The study doctors will carefully review your medical history and current medications to see if this study is suitable for you.

If you decide to participate, you will be randomly assigned to one of two groups. One group will take the new medicine, vicadrostat, combined with empagliflozin, while the other group will take a placebo (a tablet that looks the same but contains no medicine) along with empagliflozin. Both study medicines are taken as tablets once a day. You will take these medicines for a period ranging from about six months up to about 3.5 years, depending on your individual progress and how long you benefit from the treatment. Throughout the study, you can continue to take your usual heart failure medications.

You will need to attend regular visits at the study clinic. The exact number of visits will vary based on how long you stay in the study. Some of these visits might involve phone calls. During these visits, the study team will monitor your health, check for any side effects, and you'll be asked to answer questions about your well-being. Doctors will specifically keep track of any worsening heart failure symptoms, hospital stays related to heart failure, or other important health events.