A Phase 3 interventional study of balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg and balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg in Heart Failure and Impaired Kidney Function, sponsored by AstraZeneca. Recruiting at 852 sites in 39 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event.
Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:
The study will be conducted at approximately 700 sites in approximately 40 countries globally.
Exclusion Criteria:
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Drug: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Drug: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Drug: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation
Time frame: Approximately 36 months
Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total occurrences of CV death, and HF events with and without hospitalisation
Time frame: Approximately 36 months
Total occurrences (first and recurrent) of HF hospitalisations
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations
Time frame: Approximately 36 months
Time to CV death
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death
Time frame: Approximately 36 months
Time to death from any cause
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause
Time frame: Approximately 36 months
The hierarchical composite endpoint of death from any cause, total HF events, and change from baseline in KCCQ total symptom score to 24- week post-randomisation
To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause, HF events, and improving patient reported symptoms of HF
Time frame: Approximately 24 weeks
Showing the first 100 of 852 sites across 39 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol, Sap
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