Status:
RECRUITING
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Lead Sponsor:
AstraZeneca
Conditions:
Heart Failure and Impaired Kidney Function
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 11 2027
Estimated Enrollment :
4800 Patients enrolled
Trial Details
Trial ID
NCT06307652
Start Date
April 12 2024
End Date
June 11 2027
Last Update
February 18 2026
Active Locations (842)
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1
Research Site
Alexander City, Alabama, United States, 35010
2
Research Site
Birmingham, Alabama, United States, 35209
3
Research Site
Fairhope, Alabama, United States, 36532
4
Research Site
Huntsville, Alabama, United States, 35801