> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-the-effect-of-balcinrenone-dapagliflozin-63a04cc2-724d-4960-855f-dcabf44469cf > Record changed: 2026-10-13 # Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function NCT06307652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) Participants 4,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) Start date 2024-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) Number of sites 852 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Acronym** BalanceD-HF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Short title** Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Dates **Completion date** 2027-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **First posted** 2024-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Primary completion date** 2027-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Start date** 2024-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Size and sites **Participants** 4,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Planned participants** 4,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Number of sites** 852 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Identifiers **Registry ID** NCT06307652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **ClinicalTrials.gov ID** NCT06307652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Outcomes ### Primary outcomes 1. Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation Timeframe: Approximately 38 months To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation ### Secondary outcomes 1. Total occurrences (first and recurrent) of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation Timeframe: Approximately 38 months 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 2. Total occurrences (first and recurrent) of HF hospitalisations Timeframe: Approximately 38 months To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the rate of total HF hospitalisations 3. Time to CV death Timeframe: Approximately 38 months To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death 4. 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 Timeframe: Approximately 24 weeks 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 5. Time to death from any cause Timeframe: Approximately 38 months To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of death from any cause Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 130 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 18 years - Documented diagnosis of symptomatic HF (NYHA functional class II-IV) - Having had a recent HF event within 6 months (hospitalization or urgent visit) - Have a LVEF value from an assessment within the last 12 months - Managed with SoC therapy for HF and renal impairment according to local guidelines - NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter) - Not taking an MRA - An eGFR ≥ 20 to < 60 mL/min/1.73 m2 - Serum/plasma potassium ≤ 5.0 mmol/L ### Exclusion criteria - Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period - Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations - History of hypertrophic obstructive cardiomyopathy - Complex congenital heart disease or severe uncorrected primary valvular disease - Symptomatic bradycardia or second- or third-degree heart block without a pacemaker - Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours - Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment - Type 1 diabetes mellitus - Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy - Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy - Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks - Treatment with strong or moderate CYP3A4 inhibitor or inducer Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Sites - Research SiteAlexander City, United StatesRecruiting - Research SiteBirmingham, United StatesWithdrawn - Research SiteFairhope, United StatesRecruiting - Research SiteHuntsville, United StatesRecruiting - Research SitePhoenix, United StatesRecruiting - Research SitePhoenix, United StatesRecruiting - Research SiteLittle Rock, United StatesRecruiting - Research SiteBeverly Hills, United StatesRecruiting - Research SiteCovina, United StatesRecruiting - Research SiteEncinitas, United StatesTerminated - Research SiteLos Angeles, United StatesRecruiting - Research SiteLos Angeles, United StatesRecruiting - Research SiteNewport Beach, United StatesTerminated - Research SiteOrange, United StatesWithdrawn - Research SiteRedding, United StatesRecruiting - Research SiteSan Diego, United StatesRecruiting - Research SiteSan Francisco, United StatesRecruiting - Research SiteSan Francisco, United StatesRecruiting - Research SiteSanta Ana, United StatesWithdrawn - Research SiteThousand Oaks, United StatesTerminated - Research SiteVista, United StatesRecruiting - Research SiteWest Hills, United StatesRecruiting - Research SiteAurora, United StatesRecruiting - Research SiteWheat Ridge, United StatesTerminated - Research SiteAltamonte Springs, United StatesTerminated And 827 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## References - PubMed 39962632 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39962632/) Related publication ### Other registry identifiers (2) - 2023 - 2023-508162-15-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06307652) ## Related records ### Drugs (3) - [Balcinrenone](https://trialight.com/data/asset/balcinrenone-039aff61-faf5-4267-bfc5-f89dce767007.md) - [Dapagliflozin](https://trialight.com/data/asset/dapagliflozin-894f296e-52de-4036-ac69-f399eea07356.md) - [Diazepam](https://trialight.com/data/asset/diazepam-a0cb3123-d888-4bf4-b90a-171c1dcecccb.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Primary condition ### Targets (18) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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