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 Genders
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 ≥ 3.5 mmol/L and ≤ 5.0 mmol/L

Exclusion Criteria

  • 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

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
Birmingham, Alabama 35209

Research Site
Fairhope, Alabama 36532

Research Site
Huntsville, Alabama 35801

Research Site
Phoenix, Arizona 85016

Research Site
Little Rock, Arkansas 72205

Research Site
Beverly Hills, California 90211

Research Site
Encinitas, California 92024

Research Site
Los Angeles, California 90089

Research Site
Newport Beach, California 92663

Research Site
Orange, California 92868

Research Site
San Diego, California 92123

Research Site
Thousand Oaks, California 91360

Research Site
Vista, California 92081

Research Site
West Hills, California 91307

Research Site
Aurora, Colorado 80045

Research Site
Wheat Ridge, Colorado 80033

Research Site
Altamonte Springs, Florida 32701

Research Site
Clearwater, Florida 33756

Research Site
Jacksonville, Florida 32209

Research Site
Miami, Florida 33133

Research Site
Palm Beach Gardens, Florida 33410

Research Site
Safety Harbor, Florida 34695

Research Site
Saint Augustine, Florida 32086

Research Site
Atlanta, Georgia 30303

Research Site
Tucker, Georgia 30084

Research Site
Hazel Crest, Illinois 60429

Research Site
North Chicago, Illinois 60064

Research Site
Elkhart, Indiana 46514

Research Site
Hammond, Indiana 46324

Research Site
Muncie, Indiana 47303

Research Site
Munster, Indiana 46321

Research Site
Richmond, Indiana 47374

Research Site
Wichita, Kansas 67226

Research Site
Louisville, Kentucky 40202

Research Site
Shreveport, Louisiana 71105

Research Site
Rockville, Maryland 20850

Research Site
Boston, Massachusetts 02114

Research Site
Fall River, Massachusetts 02721

Research Site
Dearborn, Michigan 48126

Research Site
Flint, Michigan 48504

Research Site
Ypsilanti, Michigan 48197

Research Site
Saint Paul, Minnesota 55109

Research Site
Jackson, Mississippi 39216

Research Site
Kansas City, Missouri 64128

Research Site
Lincoln, Nebraska 68510

Research Site
Somerset, New Jersey 08873

Research Site
Bronx, New York 10451

Research Site
Bronx, New York 10455

Research Site
Staten Island, New York 10310

Research Site
Charlotte, North Carolina 28204

Research Site
Pinehurst, North Carolina 28374

Research Site
Wilmington, North Carolina 28401

Research Site
Cincinnati, Ohio 45267

Research Site
Springfield, Ohio 45504

Research Site
Oklahoma City, Oklahoma 73102

Research Site
Abington, Pennsylvania 19001

Research Site
Camp Hill, Pennsylvania 17011

Research Site
Hershey, Pennsylvania 17033

Research Site
Horsham, Pennsylvania 19044

Research Site
Providence, Rhode Island 02908

Research Site
Anderson, South Carolina 29621

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
Memphis, Tennessee 38128

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
El Paso, Texas 79905

Research Site
Houston, Texas 77002

Research Site
Houston, Texas 77025

Research Site
Katy, Texas 77493

Research Site
Mansfield, Texas 76063

Research Site
McKinney, Texas 75071

Research Site
Odessa, Texas 79761

Research Site
Pearland, Texas 77584

Research Site
Sherman, Texas 75092

Research Site
Salt Lake City, Utah 84148

Research Site
Falls Church, Virginia 22042

Research Site
Newport News, Virginia 23606

Research Site
Seattle, Washington 98101

Research Site
Tacoma, Washington 98405

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.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

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