This clinical trial is focused on studying the effects of a treatment for patients with heart failure and impaired kidney function. The treatment being tested is a combination of two medications: Balcinrenone and Dapagliflozin. The study aims to determine if this combination is more effective than using Dapagliflozin alone in reducing the risk of heart-related events and death.
Participants in the study will be randomly assigned to receive either the combination of Balcinrenone and Dapagliflozin or Dapagliflozin alone. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know which treatment each participant is receiving. This helps ensure the results are unbiased. The treatment will be administered in the form of capsules or tablets taken orally.
The study will last for a period of up to 38 weeks, during which participants will be monitored for any heart failure events, hospitalizations, or cardiovascular deaths. The goal is to see if the combination treatment can better prevent these outcomes compared to the single medication. Participants will have regular check-ups to assess their health and the effectiveness of the treatment. The study is expected to provide valuable insights into improving care for patients with heart failure and kidney issues.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, heart failure diagnosis, recent heart failure event, and kidney function.
Participants must not be taking certain medications and must have specific blood test results.
2randomization
Participants are randomly assigned to receive either the combination of balcinrenone and dapagliflozin or dapagliflozin alone.
This process ensures that the study results are unbiased.
3medication administration
Participants take the assigned medication orally. The combination of balcinrenone and dapagliflozin is provided in hard capsules, while dapagliflozin alone is provided in film-coated tablets.
The dosage and frequency are determined by the study protocol and are followed throughout the trial duration.
4monitoring and follow-up
Participants are regularly monitored for heart failure events and cardiovascular health.
Regular follow-up visits are scheduled to assess health status and any side effects.
5end of study
The study is estimated to conclude by June 2027.
Final assessments are conducted to evaluate the effectiveness of the treatment in reducing heart failure events and cardiovascular death.
Who Can Join the Study?
Must be 18 years or older.
Have a documented diagnosis of symptomatic heart failure (HF), which means the heart is not pumping blood as well as it should, and you have symptoms like shortness of breath or fatigue. This is classified as NYHA functional class II-IV, which refers to the severity of symptoms.
Have had a recent heart failure event within the last 6 months, such as a hospital stay or an urgent visit to a doctor.
Have a LVEF value from an assessment within the last 12 months. LVEF stands for Left Ventricular Ejection Fraction, which measures how well the heart is pumping.
Be managed with standard care (SoC) therapy for heart failure and kidney issues according to local guidelines.
Have a NT-proBNP level greater than 300 pg/mL, or greater than 600 pg/mL if you have atrial fibrillation or atrial flutter. NT-proBNP is a blood test that helps to diagnose heart failure. Atrial fibrillation and atrial flutter are types of irregular heartbeats.
Not be taking an MRA, which stands for Mineralocorticoid Receptor Antagonist, a type of medication.
Have an eGFR between 20 and less than 60 mL/min/1.73 m². eGFR is a test that measures how well your kidneys are working.
Have serum/plasma potassium levels between 3.5 mmol/L and 5.0 mmol/L. Potassium is a mineral in your blood that is important for heart and muscle function.
Who Cannot Join the Study?
Patients who have not experienced a recent heart failure (HF) event.
Patients without chronic heart failure.
Patients without impaired kidney function.
Patients who are not at risk of cardiovascular (CV) death.
Patients who are not at risk of heart failure events.
Balcinrenone is a medication being studied to see if it can help reduce the risk of heart failure events and cardiovascular death in patients who have heart failure and impaired kidney function. It is being tested to determine if it is more effective when used in combination with another medication, dapagliflozin.
Dapagliflozin is a medication that is already used to treat heart failure and help protect kidney function. In this study, it is being used to compare its effectiveness alone versus in combination with balcinrenone to see if the combination can provide better outcomes for patients with heart failure and impaired kidney function.
Chronic Heart Failure – Chronic heart failure is a long-term condition where the heart is unable to pump blood effectively, leading to a buildup of fluid in the lungs and other parts of the body. Over time, this can cause symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The condition often progresses slowly, with symptoms worsening as the heart becomes weaker. It can be caused by various factors, including coronary artery disease, high blood pressure, and previous heart attacks. Management of the condition focuses on improving symptoms and quality of life. Regular monitoring and lifestyle changes are often necessary to manage the disease effectively.
Chronic Kidney Disease – Chronic kidney disease is a gradual loss of kidney function over time, which can lead to the accumulation of waste products and fluid imbalances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs, and changes in urination patterns. The condition can result from diabetes, high blood pressure, or other underlying health issues. It is often detected through blood and urine tests that measure kidney function. The progression of the disease can lead to complications such as anemia, bone disease, and cardiovascular problems. Managing the condition involves lifestyle changes and regular medical check-ups to slow the progression.
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