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RecruitingPhase 3

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

AstraZeneca · NCT06307652

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–130 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
3850
US sites recruiting
104
Study start
April 12, 2024
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg; balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg; dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Conditions: Heart Failure and Impaired Kidney Function

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

+ 44 more on the official record.

Study contacts (from the official record)

  • AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
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Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in… (NCT06307652) | Bored Studies