nctId: NCT06307652 id: D6402C00012 briefTitle: Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function acronym: BalanceD-HF overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2027-06-11 date: 2027-06-11 date: 2024-03-13 date: 2024-03-13 name: AstraZeneca class: INDUSTRY briefSummary: 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. conditions: Heart Failure and Impaired Kidney Function studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 4800 type: ESTIMATED name: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg name: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg name: dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin measure: Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation measure: Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation measure: Total occurrences (first and recurrent) of HF hospitalisations measure: Time to CV death measure: 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 measure: Time to death from any cause sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Alexander City state: Alabama zip: 35010 country: United States lat: 32.94401 lon: -85.95385 facility: Research Site city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site city: Little Rock state: Arkansas zip: 72205 country: United States lat: 34.74648 lon: -92.28959 facility: Research Site city: Los Angeles state: California 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