This clinical trial is focused on studying the prevention of Heart Failure in individuals who are at an increased risk of developing this condition. The study will evaluate the effects of a medication called Baxdrostat, which will be used in combination with another medication known as Dapagliflozin. These medications will be compared to the use of Dapagliflozin alone. The purpose of the study is to determine if the combination of Baxdrostat and Dapagliflozin is more effective in reducing the risk of heart failure events or cardiovascular death.
Participants in the study will be randomly assigned to receive either the combination of Baxdrostat and Dapagliflozin, Dapagliflozin alone, or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will continue until a certain number of heart failure events or cardiovascular deaths occur among the participants, which will help determine the effectiveness of the treatments being tested.
The trial will involve taking the medications in the form of tablets, which are to be taken orally. The study is designed to last for a maximum of 38 weeks. Participants will be monitored throughout the study to assess the occurrence of heart failure events, hospitalizations, and any cardiovascular-related deaths. The results of this study will help to understand the potential benefits of using Baxdrostat in combination with Dapagliflozin for individuals at risk of heart failure.
1joining the study
Upon joining the study, participants will be randomly assigned to one of two groups. One group will receive a combination of baxdrostat and dapagliflozin, while the other group will receive a placebo with dapagliflozin.
The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.
2medication administration
Participants will take the medications orally in the form of tablets. Baxdrostat and dapagliflozin are both administered as tablets, with dapagliflozin being a film-coated tablet.
The dosage and frequency of the medication will be determined by the study protocol and communicated to participants at the start of the trial.
3monitoring and follow-up
Throughout the study, participants will be monitored for any signs of heart failure or cardiovascular events. This includes regular check-ups and assessments to track health status.
Participants will be required to report any hospitalizations or significant health changes to the study team promptly.
4study duration
The study is expected to continue until December 2029. Participants will be involved in the study for the entire duration unless they choose to withdraw or are advised to stop for health reasons.
Regular updates and information will be provided to participants throughout the study period.
Who Can Join the Study?
Participants of any sex and gender must be 40 years or older at the time of signing the informed consent.
Must have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and require treatment. T2DM is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Must have established cardiovascular (CV) disease, which includes conditions like ischaemic heart disease, cerebrovascular disease, or peripheral arterial disease. These are diseases related to the heart and blood vessels.
Must have a history of hypertension (HTN), which is high blood pressure, and a systolic blood pressure (SBP) of 130 mmHg or higher at screening and 120 mmHg or higher at the Randomisation Visit.
Central laboratory serum potassium levels must meet specific criteria at the Screening Visit, based on kidney function measured by eGFR (estimated Glomerular Filtration Rate):
For participants with eGFR 45 mL/min/1.73 m² or higher, potassium must be between 3.0 and 4.8 mmol/L.
For participants with eGFR less than 45 mL/min/1.73 m², potassium must be between 3.0 and 4.5 mmol/L.
Must have at least one additional risk factor for heart failure (HF), such as:
Age 70 years or older
UACR (Urine Albumin-to-Creatinine Ratio) greater than 20 mg/g
eGFR less than 60 mL/min/1.73 m²
History of polyvascular disease (having at least two of the following: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
History of atrial fibrillation or atrial flutter, which are types of irregular heartbeats
NT-proBNP (a marker of heart stress) greater than 125 ng/L
All women of childbearing potential (WOCBP) must have a negative pregnancy test result at screening and must not be breastfeeding.
Who Cannot Join the Study?
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population are not eligible.
Patients with medical conditions other than the prevention of heart failure may be excluded.
Patients who are not able to follow the study procedures or take the study medication as required will be excluded.
Patients who are currently participating in another clinical trial cannot join this study.
Patients with a history of certain medical conditions that could interfere with the study results may be excluded.
Patients who have had a recent heart attack or stroke may not be eligible.
Patients with severe kidney or liver disease may be excluded.
Patients who are allergic to any of the study medications cannot participate.
Patients who are pregnant or breastfeeding are not eligible for the study.
Baxdrostat is a medication being studied to see if it can help reduce the risk of heart failure and cardiovascular death. It is being tested in combination with another medication to see if it provides better protection for the heart compared to using the other medication alone. The goal is to find out if adding Baxdrostat can make a significant difference in preventing heart-related problems.
Dapagliflozin is a medication that is already used to help manage certain heart conditions and diabetes. In this study, it is being used as a standard treatment to see if adding another medication, Baxdrostat, can improve its effectiveness in reducing the risk of heart failure and cardiovascular death. Dapagliflozin works by helping the body remove excess sugar through urine, which can also have benefits for heart health.
Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body’s needs. It often begins with the heart’s inability to fill with enough blood or pump with enough force. As the condition progresses, fluid may build up in the lungs, liver, and other parts of the body, leading to symptoms like shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart’s pumping ability continues to weaken, which can lead to more severe symptoms and complications. The progression of heart failure can vary, with periods of stability followed by episodes of worsening symptoms. It is a chronic condition that requires ongoing management to control symptoms and improve quality of life.
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