Balcinrenone/dapagliflozin for heart failure (BalanceD-HF)

Resolution Criteria Trial: NCT06307652 Selected endpoint key: fc8e0830b0e3eff9c77f7931414e3bad2b8809edf644bfeb65122fdc4e3fad68 Selected endpoint: Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation Endpoint type: composite Protocol outcome group: primary Endpoint description: To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation Endpoint timeframe: Approximately 36 months ClinicalTrials.gov population: Patients with heart failure and impaired kidney function. Market population: Patients with heart failure and impaired kidney function. Analysis set: Not specified in the enumerated ClinicalTrials.gov outcome. Comparison: Balcinrenone/dapagliflozin versus dapagliflozin. Success direction: superiority Success rule: In patients with heart failure and impaired kidney function, balcinrenone/dapagliflozin must be superior to dapagliflozin by reducing the risk of time to first occurrence of cardiovascular death, heart-failure hospitalisation, or a heart-failure event without hospitalisation, assessed over approximately 36 months, and must meet the prespecified statistical success criterion. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06307652?tab=researcher#outcome-measures:~:text=Time%20to%20first%20occurrence%20of%20any%20of%20the%20components%20of%20the%20composite%20of%3A%20%E2%80%A2CV%20death%20%E2%80%A2HF%20hospitalisation%20%E2%80%A2HF%20event%20without%20hospitalisation YES 1. The exact selected endpoint (Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-12-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 94/100): official source supports 2027-01-01 through 2027-12-31; market deadline 2027-12-31 is the conservative end of that window. AstraZeneca's official 2025 Form 20-F states that its Phase III development-pipeline table provides anticipated data timing and submission status and lists balcinrenone/dapagliflozin for heart failure with CKD with timing of 2027. Because the official evidence supports only a calendar year rather than an exact day, the conservative market deadline is the last calendar day of 2027. Deadline evidence source: https://www.sec.gov/Archives/edgar/data/901832/000110465926019130/azn-20251231x20f.htm Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.