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

Description

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.

Conditions

Heart Failure and Impaired Kidney Function

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Heart Failure and Impaired Kidney Function
Intervention / Treatment

-

Contacts and Locations

Alexander City

Research Site, Alexander City, Alabama, United States, 35010

Birmingham

Research Site, Birmingham, Alabama, United States, 35209

Fairhope

Research Site, Fairhope, Alabama, United States, 36532

Huntsville

Research Site, Huntsville, Alabama, United States, 35801

Little Rock

Research Site, Little Rock, Arkansas, United States, 72205

Beverly Hills

Research Site, Beverly Hills, California, United States, 90211

Encinitas

Research Site, Encinitas, California, United States, 92024

Los Angeles

Research Site, Los Angeles, California, United States, 90073

Los Angeles

Research Site, Los Angeles, California, United States, 90089

Newport Beach

Research Site, Newport Beach, California, United States, 92663

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥ 3.5 mmol/L and ≤ 5.0 mmol/L
  • * Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
  • * 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
  • * 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 \< 100 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-06-11