Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

This study is looking for adults aged 18 or over who have been diagnosed with symptomatic heart failure and have also had a recent heart failure event, such as a hospital stay, within the last six months. You would also need to be receiving the standard recommended treatments for your heart failure and kidney problems, as advised by your local doctors.

There are also specific medical requirements related to your kidney function and certain blood test results, such as for a hormone called NT-proBNP and potassium levels. For instance, your kidney function needs to be within a certain range, and you shouldn't be taking a specific type of medication called an MRA.

You wouldn't be able to join the study if you've had certain serious heart events (like a heart attack or major heart surgery) or other medical conditions recently, such as a recent stroke, uncontrolled high or low blood pressure, severe lung disease, or Type 1 diabetes. Other reasons for not being able to participate include having recently received or currently needing kidney dialysis, severe liver disease, suspected or confirmed COVID-19 infection within a certain timeframe, or taking particular medications that might interfere with the study drugs.

If you decide to take part in this study, you would be randomly assigned to one of three treatment groups. You would receive either one of the two doses of the new balcinrenone/dapagliflozin combination, or dapagliflozin, along with a placebo (an inactive tablet or capsule that looks like the active drug but has no medicine in it). This ensures that neither you nor your study doctor knows which specific treatment you are receiving, making the study fair and scientific.

The treatment would involve taking one capsule and one tablet once daily. The study is designed to last about 22 months for each person. This includes an initial checking period, roughly 20 months where you'll be taking the study medication and attending regular appointments, and a one-month follow-up period where you'll be taking open-label dapagliflozin (meaning you'll know you're taking dapagliflozin and it won't be a placebo). During this time, you'll have various check-ups, tests, and assessments to monitor your health and the effects of the treatment. You are always free to leave the study at any time.