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dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin / balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 / Heart Failure and Impaired Kidney Function · Phase 3 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 RCT comparing balcinrenone/dapagliflozin combination therapy to dapagliflozin alone in heart failure with impaired kidney function. The study is ongoing with no results currently posted in this registry record; the planned primary endpoint is time to first occurrence of cardiovascular death, heart failure hospitalisation, or heart failure events without hospitalisation over approximately 36 months.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Heart Failure and Impaired Kidney Function; age from 18 Years; to 130 Years. Intervention: balcinrenone/dapagliflozin 15 mg/10 mg; balcinrenone/dapagliflozin 40 mg/10 mg. Compared with: dapagliflozin 10 mg — Active Comparator. n = 3,850. 852 sites across 39 countries.
This is a registered Phase 3 RCT comparing balcinrenone/dapagliflozin combination therapy to dapagliflozin alone in heart failure with impaired kidney function. The study is ongoing with no results currently posted in this registry record; the planned primary endpoint is time to first occurrence of cardiovascular death, heart failure hospitalisation, or heart failure events without hospitalisation over approximately 36 months.
No efficacy or safety results are reported in this registry record
When results become available, this trial will directly address whether adding a finerenone-class agent (balcinrenone) to SGLT2 inhibition provides incremental benefit for hard cardiovascular and heart failure outcomes in HF with kidney disease. The strength of evidence is currently insufficient to inform practice pending outcome publication.
This is a Phase 3 RCT registry record with no posted results; the study is actively recruiting and outcomes are not yet reported.
As stated by the source record.
Quoted from the source exactly as published.
When results become available, this trial will directly address whether adding a finerenone-class agent (balcinrenone) to SGLT2 inhibition provides incremental benefit for hard cardiovascular and heart failure outcomes in HF with kidney disease. The strength of evidence is currently insufficient to inform practice pending outcome publication.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06307652). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 3850 participants (ESTIMATED). Conditions: Heart Failure and Impaired Kidney Function. Interventions: DRUG: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg; DRUG: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg; DRUG: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin. Primary outcome measures: Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation , Approximately 36 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.