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 4829843, Alabama 4829764 35010

Research Site
Fairhope 4061234, Alabama 4829764 36532

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Huntsville 4068590, Alabama 4829764 35801

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Phoenix 5308655, Arizona 5551752 85016

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Little Rock 4119403, Arkansas 4099753 72205

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Beverly Hills 5328041, California 5332921 90211

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Covina 5340175, California 5332921 91723

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Encinitas 5346646, California 5332921 92024

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Los Angeles 5368361, California 5332921 90073

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Los Angeles 5368361, California 5332921 90089

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Redding 5570160, California 5332921 96001

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San Diego 5391811, California 5332921 92123

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San Francisco 5391959, California 5332921 94110

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San Francisco 5391959, California 5332921 94121

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Vista 5406602, California 5332921 92081

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West Hills 8030162, California 5332921 91307

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Aurora 5412347, Colorado 5417618 80045

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Boca Raton 4148411, Florida 4155751 33486

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Bradenton 4148708, Florida 4155751 34209

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Fort Lauderdale 4155966, Florida 4155751 33308

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Gainesville 4156404, Florida 4155751 32610

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Jacksonville 4160021, Florida 4155751 32209

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Miami 4164138, Florida 4155751 33133

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Miami 4164138, Florida 4155751 33176

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Miami Lakes 4164186, Florida 4155751 33014

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Palm Beach Gardens 4167519, Florida 4155751 33410

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Pensacola 4168228, Florida 4155751 32503

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Port Charlotte 4169130, Florida 4155751 33952

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Safety Harbor 4170797, Florida 4155751 34695

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Saint Augustine 4170894, Florida 4155751 32086

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Tampa 4174757, Florida 4155751 33617

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Atlanta 4180439, Georgia 4197000 30303

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Peachtree City 4215110, Georgia 4197000 30269

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Tucker 4227213, Georgia 4197000 30084

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Chicago 4887398, Illinois 4896861 60637

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Glenview 4893886, Illinois 4896861 60026

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Hazel Crest 4895416, Illinois 4896861 60429

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North Chicago 4903862, Illinois 4896861 60064

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Winfield 4916826, Illinois 4896861 60190

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Elkhart 4919987, Indiana 4921868 46514

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Hammond 4921100, Indiana 4921868 46324

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Muncie 4924006, Indiana 4921868 47303

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Munster 4924014, Indiana 4921868 46321

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Waterloo 4880889, Iowa 4862182 50701

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Wichita 4281730, Kansas 4273857 67226

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West Monroe 4345850, Louisiana 4331987 71291

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Rockville 4367175, Maryland 4361885 20850

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Boston 4930956, Massachusetts 6254926 02114

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Bloomfield Hills 4986429, Michigan 5001836 48304

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Farmington Hills 4992523, Michigan 5001836 48334

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Flint 4992982, Michigan 5001836 48504

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Ypsilanti 5015688, Michigan 5001836 48197

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Saint Paul 5045360, Minnesota 5037779 55109

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Jackson 4431410, Mississippi 4436296 39216

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Columbia 4381982, Missouri 4398678 65201

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Kansas City 4393217, Missouri 4398678 64111

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Kansas City 4393217, Missouri 4398678 64128

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Lincoln 5072006, Nebraska 5073708 68510

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Somerset 5104755, New Jersey 5101760 08873

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New York 5128581, New York 5128638 10029

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Staten Island 5139568, New York 5128638 10310

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The Bronx 5110266, New York 5128638 10451

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The Bronx 5110266, New York 5128638 10455

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Asheville 4453066, North Carolina 4482348 28801

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Chapel Hill 4460162, North Carolina 4482348 27517

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Charlotte 4460243, North Carolina 4482348 28204

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Durham 4464368, North Carolina 4482348 27710

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Pinehurst 4485272, North Carolina 4482348 28374

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Statesville 4493316, North Carolina 4482348 28625

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Wilmington 4499379, North Carolina 4482348 28401

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Cincinnati 4508722, Ohio 5165418 45267

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Dayton 4509884, Ohio 5165418 45414

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Springfield 4525353, Ohio 5165418 45504

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Abington 5177773, Pennsylvania 6254927 19001

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Camp Hill 5182928, Pennsylvania 6254927 17011

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Hershey 5193342, Pennsylvania 6254927 17033

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Providence 5224151, Rhode Island 5224323 02908

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Charleston 4574324, South Carolina 4597040 29401

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Charleston 4574324, South Carolina 4597040 29425

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Lancaster 4584556, South Carolina 4597040 29720

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Rapid City 5768233, South Dakota 5769223 57701

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Jackson 4632595, Tennessee 4662168 38305

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Knoxville 4634946, Tennessee 4662168 37916

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Memphis 4641239, Tennessee 4662168 38120

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Nashville 4644585, Tennessee 4662168 37212

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Tullahoma 4663494, Tennessee 4662168 37388

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Allen 4670300, Texas 4736286 75013

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Amarillo 5516233, Texas 4736286 79106

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Amarillo 5516233, Texas 4736286 79121

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Cypress 4684724, Texas 4736286 77429

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Dallas 4684888, Texas 4736286 75216

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Dallas 4684888, Texas 4736286 75390

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El Paso 5520993, Texas 4736286 79905

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Houston 4699066, Texas 4736286 77002

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Houston 4699066, Texas 4736286 77025

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Mansfield 4709013, Texas 4736286 76063

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McKinney 4710178, Texas 4736286 75069

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McKinney 4710178, Texas 4736286 75071

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Odessa 5527554, Texas 4736286 79761

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Tyler 4738214, Texas 4736286 75701

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Tyler 4738214, Texas 4736286 75702

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Salt Lake City 5780993, Utah 5549030 84148

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Falls Church 4758390, Virginia 6254928 22042

Research Site
Newport News 4776024, Virginia 6254928 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