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Evaluating Balcinrenone and Dapagliflozin for Heart Failure with Kidney Issues

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

Phase 3 Interventional AstraZeneca · NCT06307652

This study is testing if a combination of two medications, balcinrenone and dapagliflozin, can help people with heart failure and kidney problems feel better compared to taking dapagliflozin alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4800 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations845 sites (Alexander City, Alabama and 844 other locations)
Trial IDNCT06307652 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial investigates the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients suffering from chronic heart failure and impaired kidney function. Participants will be randomly assigned to receive one of three treatment regimens, including varying doses of balcinrenone/dapagliflozin or dapagliflozin with matching placebos. The study aims to assess the impact of these treatments on cardiovascular death and heart failure events over an average duration of 22 months. Conducted across approximately 700 sites in 40 countries, this trial seeks to provide insights into effective management strategies for patients with these conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic heart failure, recent heart failure events, and impaired kidney function.

Not a fit: Patients with acute coronary syndrome, recent major cardiac surgeries, or specific heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with heart failure and impaired kidney function, potentially reducing cardiovascular deaths and heart failure events.

How similar studies have performed: Other studies have shown promise in treating heart failure with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Alexander City, Alabama and 844 other locations

+795 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure and Impaired Kidney Function
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.