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

Purpose

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.

Condition

  • Heart Failure and Impaired Kidney Function

Eligibility

Eligible Ages
Between 18 Years and 130 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
balcinrenone/dapagliflozin 15 mg/10 mg 		Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
  • Drug: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
    1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Experimental
balcinrenone/dapagliflozin 40 mg/10 mg 		Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
  • Drug: balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
    1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Active Comparator
dapagliflozin 10 mg 		Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
  • Drug: dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
    1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Recruiting Locations

Research Site
Alexander City, Alabama 35010

Research Site
Fairhope, Alabama 36532

Research Site
Huntsville, Alabama 35801

Research Site
Phoenix, Arizona 85016

Research Site
Phoenix, Arizona 85044

Research Site
Little Rock, Arkansas 72205

Research Site
Beverly Hills, California 90211

Research Site
Covina, California 91723

Research Site
Encinitas, California 92024

Research Site
Los Angeles, California 90073

Research Site
Los Angeles, California 90089

Research Site
Redding, California 96001

Research Site
San Diego, California 92123

Research Site
San Francisco, California 94110

Research Site
San Francisco, California 94121

Research Site
Vista, California 92081

Research Site
West Hills, California 91307

Research Site
Aurora, Colorado 80045

Research Site
Boca Raton, Florida 33486

Research Site
Bradenton, Florida 34209

Research Site
Delray Beach, Florida 33484

Research Site
Fort Lauderdale, Florida 33308

Research Site
Gainesville, Florida 32610

Research Site
Jacksonville, Florida 32209

Research Site
Miami, Florida 33176

Research Site
Miami Lakes, Florida 33014

Research Site
Palm Beach Gardens, Florida 33410

Research Site
Pensacola, Florida 32503

Research Site
Port Charlotte, Florida 33952

Research Site
Safety Harbor, Florida 34695

Research Site
Saint Augustine, Florida 32086

Research Site
St. Petersburg, Florida 33701

Research Site
Tampa, Florida 33617

Research Site
Atlanta, Georgia 30303

Research Site
Atlanta, Georgia 30309

Research Site
Peachtree City, Georgia 30269

Research Site
Thomasville, Georgia 31792

Research Site
Tucker, Georgia 30084

Research Site
Chicago, Illinois 60637

Research Site
Glenview, Illinois 60026

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Hazel Crest, Illinois 60429

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North Chicago, Illinois 60064

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Peoria, Illinois 61614

Research Site
Winfield, Illinois 60190

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Elkhart, Indiana 46514

Research Site
Hammond, Indiana 46324

Research Site
Muncie, Indiana 47303

Research Site
Munster, Indiana 46321

Research Site
Waterloo, Iowa 50701

Research Site
Wichita, Kansas 67226

Research Site
West Monroe, Louisiana 71291

Research Site
Rockville, Maryland 20850

Research Site
Boston, Massachusetts 02114

Research Site
Worcester, Massachusetts 01655

Research Site
Bloomfield Hills, Michigan 48304

Research Site
Farmington Hills, Michigan 48334

Research Site
Flint, Michigan 48504

Research Site
Ypsilanti, Michigan 48197

Research Site
Saint Paul, Minnesota 55109

Research Site
Jackson, Mississippi 39216

Research Site
Columbia, Missouri 65201

Research Site
Kansas City, Missouri 64111

Research Site
Kansas City, Missouri 64128

Research Site
Lincoln, Nebraska 68506

Research Site
Lincoln, Nebraska 68510

Research Site
Henderson, Nevada 89074

Research Site
Somerset, New Jersey 08873

Research Site
New York, New York 10029

Research Site
Staten Island, New York 10310

Research Site
The Bronx, New York 10451

Research Site
The Bronx, New York 10455

Research Site
Asheville, North Carolina 28801

Research Site
Chapel Hill, North Carolina 27517

Research Site
Charlotte, North Carolina 28204

Research Site
Durham, North Carolina 27710

Research Site
Pinehurst, North Carolina 28374

Research Site
Statesville, North Carolina 28625

Research Site
Wilmington, North Carolina 28401

Research Site
Cincinnati, Ohio 45219

Research Site
Cincinnati, Ohio 45267

Research Site
Dayton, Ohio 45414

Research Site
Springfield, Ohio 45504

Research Site
Abington, Pennsylvania 19001

Research Site
Camp Hill, Pennsylvania 17011

Research Site
Hershey, Pennsylvania 17033

Research Site
Philadelphia, Pennsylvania 19104

Research Site
Providence, Rhode Island 02908

Research Site
Charleston, South Carolina 29401

Research Site
Charleston, South Carolina 29425

Research Site
Lancaster, South Carolina 29720

Research Site
Rapid City, South Dakota 57701

Research Site
Jackson, Tennessee 38305

Research Site
Knoxville, Tennessee 37916

Research Site
Memphis, Tennessee 38120

Research Site
Nashville, Tennessee 37212

Research Site
Tullahoma, Tennessee 37388

Research Site
Allen, Texas 75013

Research Site
Amarillo, Texas 79106

Research Site
Amarillo, Texas 79121

Research Site
Cypress, Texas 77429

Research Site
Dallas, Texas 75204

Research Site
Dallas, Texas 75216

Research Site
Dallas, Texas 75390

Research Site
El Paso, Texas 79905

Research Site
Houston, Texas 77002

Research Site
Houston, Texas 77025

Research Site
McKinney, Texas 75069

Research Site
McKinney, Texas 75071

Research Site
Odessa, Texas 79761

Research Site
Temple, Texas 76508

Research Site
Tyler, Texas 75701

Research Site
Tyler, Texas 75702

Research Site
Salt Lake City, Utah 84148

Research Site
Falls Church, Virginia 22042

Research Site
Newport News, Virginia 23606

More Details

NCT ID
NCT06307652
Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

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 chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center