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

What this 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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Research Site, Alexander City, Alabama, United States
• Research Site, Birmingham, Alabama, United States
• Research Site, Fairhope, Alabama, United States
• Research Site, Huntsville, Alabama, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Little Rock, Arkansas, United States
• Research Site, Beverly Hills, California, United States
• Research Site, Covina, California, United States
• Research Site, Encinitas, California, United States
• Research Site, Los Angeles, California, United States
• Research Site, Los Angeles, California, United States

+ 840 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06307652.