Who is eligible for clinical trial NCT06307652?

Participants must meet the protocol's inclusion criteria for Heart Failure and Impaired Kidney Function. The stated age range is 18 Years to 130 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06307652 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-25

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function (NCT06307652)

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

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (13 items).

Location: Research Site — Alexander City, Alabama

Age range: 18 Years to 130 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (852 Sites)

Showing the first 25 of 852 sites.

Research Site — Alexander City, Alabama
Research Site — Birmingham, Alabama
Research Site — Fairhope, Alabama
Research Site — Huntsville, Alabama
Research Site — Phoenix, Arizona
Research Site — Phoenix, Arizona
Research Site — Little Rock, Arkansas
Research Site — Beverly Hills, California
Research Site — Covina, California
Research Site — Encinitas, California
Research Site — Los Angeles, California
Research Site — Los Angeles, California
Research Site — Newport Beach, California
Research Site — Orange, California
Research Site — Redding, California
Research Site — San Diego, California
Research Site — San Francisco, California
Research Site — San Francisco, California
Research Site — Santa Ana, California
Research Site — Thousand Oaks, California
Research Site — Vista, California
Research Site — West Hills, California
Research Site — Aurora, Colorado
Research Site — Wheat Ridge, Colorado
Research Site — Altamonte Springs, Florida

📞 Contact the Study Coordinator

Phone: (877) 240-9479

Email: information.center@astrazeneca.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Heart Failure and Impaired Kidney Function clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗