Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

To be considered for this study, you would generally need to be at least 40 years old. You must have type 2 diabetes, established heart or blood vessel disease (like a previous heart attack or stroke), and high blood pressure that is fairly well controlled, usually with a top number (systolic blood pressure) around 130 mmHg at the start. You'd also need at least one additional risk factor for heart failure, such as being over 70, having certain kidney issues, a history of atrial fibrillation, or more widespread blood vessel disease.

However, some things would mean you couldn't join. For example, if you've already been diagnosed with and treated for heart failure, or if your kidneys are not working properly (eGFR less than 30). Also, if you have very high levels of potassium in your blood, previously diagnosed type 1 diabetes, or uncontrolled type 2 diabetes, you wouldn't be able to take part. Recent serious health events like a heart attack, stroke, or major surgery within the last few months, or certain liver or adrenal gland problems, would also exclude you. We'd also check to make sure you're not taking any medications that would interfere with the study drugs.

If you decide to take part, you'll first have an initial health check to see if you meet the study requirements. This might include blood tests, blood pressure checks, and a review of your health history. If you are eligible but not already on dapagliflozin, or have been on it for a short time, you'll start taking dapagliflozin 10mg once daily for about 4 to 6 weeks before the main part of the study begins. During the main study, you'll be randomly assigned to receive either the active study drug combination (Baxdrostat + dapagliflozin) or a dummy pill (placebo + dapagliflozin). You won't know which group you are in, and neither will your study doctor.

You'll have regular hospital visits at specific times: around 2, 4, 8, 16, and 34 weeks after starting the active part of the study. After that, visits will generally be every 4 months. These visits will involve health checks, blood tests, and discussions about how you're feeling. The study will continue until a certain number of heart failure-related events or deaths have occurred in the overall participant group. If you stop taking the study medication early, you will typically continue to receive dapagliflozin and still be followed up according to the study schedule, so that researchers can gather as much information as possible.