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

Recruiting · NCT06307652 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgbalcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mgdapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

What this trial 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 take part

Age range

18 Years to 130 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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 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
Treatment with strong or moderate CYP3A4 inhibitor or inducer

Where it is running

60 locations listed across 37 US states.

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
Research Site - Newport Beach, California, United States
Research Site - Orange, California, United States
Research Site - Redding, California, United States
Research Site - San Diego, California, United States
Research Site - San Francisco, California, United States
Research Site - San Francisco, California, United States
Research Site - Santa Ana, California, United States
Research Site - Thousand Oaks, California, United States
Research Site - Vista, California, United States
Research Site - West Hills, California, United States
Research Site - Aurora, Colorado, United States
Research Site - Wheat Ridge, Colorado, United States
Research Site - Altamonte Springs, Florida, United States
Research Site - Boca Raton, Florida, United States
Research Site - Bradenton, Florida, United States
Research Site - Clearwater, Florida, United States
Research Site - Delray Beach, Florida, United States
Research Site - Fort Lauderdale, Florida, United States
Research Site - Gainesville, Florida, United States
Research Site - Jacksonville, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami Lakes, Florida, United States
Research Site - Palm Beach Gardens, Florida, United States
Research Site - Pensacola, Florida, United States
Research Site - Port Charlotte, Florida, United States
Research Site - Safety Harbor, Florida, United States
Research Site - Saint Augustine, Florida, United States
Research Site - St. Petersburg, Florida, United States
Research Site - Tampa, Florida, United States
Research Site - Atlanta, Georgia, United States
Research Site - Atlanta, Georgia, United States
Research Site - Peachtree City, Georgia, United States
Research Site - Thomasville, Georgia, United States
Research Site - Tucker, Georgia, United States
Research Site - Chicago, Illinois, United States
Research Site - Chicago, Illinois, United States
Research Site - Glenview, Illinois, United States
Research Site - Hazel Crest, Illinois, United States
Research Site - North Chicago, Illinois, United States
Research Site - Peoria, Illinois, United States
Research Site - Winfield, Illinois, United States
Research Site - Elkhart, Indiana, United States
Research Site - Evansville, Indiana, United States
Research Site - Hammond, Indiana, United States
Research Site - Indianapolis, Indiana, United States
Research Site - Muncie, Indiana, United States
Research Site - Munster, Indiana, United States

Showing 60 of 852 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →