Phase III study to evaluate the effect of balcinrenone/dapagliflozin in patients with heart failure and impaired kidney functio

Phase 1

Recruiting

• Conditions: Chronic HF and comorbid impairment of kidney function who had a recent HF event to evaluatethe effect of balcinrenone/dapagliflozin versus dapagliflozin alone on HF events and cardiovascular (CV) death; MedDRA version: 20.0Level: PTClassification code: 10007554Term: Cardiac failure Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508162-15-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4800

Inclusion Criteria

1. Age = 18 years, 2. Documented diagnosis of symptomatic HF (NYHA functional class II-IV), 3. Having had a recent HF event within 6 months (hospitalization or urgent visit), 4. Have a LVEF value from an assessment within the last 12 months, 5. Managed with SoC therapy for HF and renal impairment according to local guidelines, 6. NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter), 7. Not taking an MRA, 8. An eGFR = 20 to < 60 mL/min/1.73 m2, 9. Serum/plasma potassium = 3.5 mmol/L and = 5.0 mmol/

Exclusion Criteria

1. Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months, 8. Type 1 diabetes mellitus, 9. Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy, 12. Treatment with strong or moderate CYP3A4 inhibitor or inducer, 10. Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening, 11. Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks, 2. 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 planned to undergo any of these operations, 3. History of hypertrophic obstructive cardiomyopathy, 4. Complex congenital heart disease or severe uncorrected primary valvular disease, 5. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker, 6. Systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours, 7. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified