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Study of Balcinrenone/Dapagliflozin for Heart Failure and Impaired Kidney Function

This study is looking at balcinrenone/dapagliflozin compared to dapagliflozin in people with heart failure and impaired kidney function who have recently had a heart failure event. The goal is to see if balcinrenone/dapagliflozin can reduce the risk of death from heart problems and other heart failure events. You might be able to join if you are 18 or older, have symptomatic heart failure (NYHA functional class II-IV), and have had a recent heart failure event within the last 6 months. Your NT-proBNP (a biomarker for heart failure) must also be above a certain level. The study will consider balcinrenone/dapagliflozin successful if it reduces the time to the first occurrence of cardiovascular death, heart failure hospitalization, or a heart failure event without hospitalization over approximately 38 months. The current recruitment status is unclear.

Study design
This is a large, international, randomized, double-blind, parallel-group study involving 4800 participants. Participants will be randomly assigned to receive one of three treatment combinations.
What's involved
Participants will take one capsule and one tablet once daily. The average study duration for a participant is estimated to be 22 months, including a screening period, 20 months of blinded treatment, and a one-month follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a one-month follow-up period on open-label dapagliflozin after the blinded treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06307652

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~3,850 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgbalcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mgdapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

At a glance

Recruiting sites
631 of 852 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation
Measured over Approximately 36 months

Conditions

Heart Failure and Impaired Kidney Function

Explore related trials

Chronic Kidney DiseaseHeart Failure

NCT06307652

Where you'd take part

This study runs at 852 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Alexander City, Alabamano site contact published

    Recruiting

  • Research Site

    Fairhope, Alabamano site contact published

    Recruiting

  • Research Site

    Huntsville, Alabamano site contact published

    Recruiting

  • Research Site

    Phoenix, Arizonano site contact published

    Recruiting

  • Research Site

    Phoenix, Arizonano site contact published

    Recruiting

  • Research Site

    Little Rock, Arkansasno site contact published

    Recruiting

  • Research Site

    Beverly Hills, Californiano site contact published

    Recruiting

  • Research Site

    Covina, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisationApproximately 36 months

    To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation