BalanceD-HF
Research type
Research Study
Full title
A Phase III, Randomised, Double-blind Study to Evaluate theEffect of Balcinrenone/Dapagliflozin, Compared withDapagliflozin, on the Risk of Heart Failure Events andCardiovascular Death in Patients with Heart Failure and ImpairedKidney Function
IRAS ID
1009392
Contact name
Arbab Bhatti
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2023-508162-15
Research summary
Heart failure affects more than 64 million people worldwide and continues to be a major cause of death, hospitalisation, and poor quality of life. The goal of HF treatments is to improve the patient’s clinical status, functional capacity and quality of life, prevent hospital admission, and reduce mortality. Mineralocorticoid receptor antagonists and SGLT2 inhibitors independently reduce progression of heart failure and chronic kidney disease via different mechanisms, and are thus expected to exhibit complementary benefits. MRAs are an important standard of care therapy for heart failure with LVEF < 40%, but are underused in patients with reduced kidney function due to safety concerns of hyperkalemia and an initial reduction in eGFR.
In the current study, AstraZeneca is evaluating if balcinrenone, a mineral corticoid receptor modulator with predicted similar clinical benefits as MRAs, but with less safety concerns, working together with dapagliflozin, a SGLT2 inhibitor, is better than dapagliflozin alone in reducing the risk of cardiovascular death and heart failure events with or without hospitalization in patients with heart failure and reduced kidney function. This is a global, event-driven study, lasting approximately 38 months.
Patients will be randomly assigned to either the a combination of balcinrenone and dapagliflozin or dapagliflozin alone at the start of the study and the treatment each patient receives will not be known to AstraZeneca or their doctor. Study patients will have their medical history reviewed, have an ECG, blood and urine tests and vital signs taken, complete questionnaires and have physical examinations performed to check on their overall health and wellbeing. Following enrolment into the study, visits will be completed at 1 day, 7 days, 28 days, 56 days, 112 days, 168 days and thereafter approximately every 2 or 4 months until the study closes.REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0018
Date of REC Opinion
17 Apr 2024
REC opinion
Further Information Favourable Opinion