Phase 3Recruiting
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function (BalanceD-HF)
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
- Sponsor
- AstraZeneca (Industry)
- Enrolment
- 3,850 planned
- Conditions
- Heart Failure and Impaired Kidney Function
- Interventions
- balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg; balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg; dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
- Ages
- adults, older adults
- Registry
- NCT06307652
From the registry
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Primary outcomes
- Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation