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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Heart Failure and Impaired Kidney Function

In brief

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.

Key facts

Study ID

NCT06307652

Run by

AstraZeneca

People needed

4800

Starts

2024-04-12

Expected to finish

2027-06-11

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Research Site — Delray Beach, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Boca Raton, Florida, United States (enrolling)
• Research Site — Bradenton, Florida, United States (enrolling)
• Research Site — Gainesville, Florida, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — Beverly Hills, California, United States (enrolling)
• Research Site — Huntsville, Alabama, United States (enrolling)
• Research Site — Alexander City, Alabama, United States (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — Fort Lauderdale, Florida, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Little Rock, Arkansas, United States (enrolling)
• Research Site — Redding, California, United States (enrolling)
• Research Site — San Diego, California, United States (enrolling)
• Research Site — San Francisco, California, United States (enrolling)
• Research Site — San Francisco, California, United States (enrolling)
• Research Site — Covina, California, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Vista, California, United States (enrolling)
• Research Site — West Hills, California, United States (enrolling)
• Research Site — Aurora, Colorado, United States (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — Fairhope, Alabama, United States (enrolling)
• Research Site — Miami Lakes, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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