RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-12
Study Completion:2027-06-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06307652

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.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
  3. * Having had a recent HF event within 6 months (hospitalization or urgent visit)
  4. * Have a LVEF value from an assessment within the last 12 months
  5. * Managed with SoC therapy for HF and renal impairment according to local guidelines
  6. * NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
  7. * Not taking an MRA
  8. * An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
  9. * Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L
  1. * Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
  2. * 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
  3. * History of hypertrophic obstructive cardiomyopathy
  4. * Complex congenital heart disease or severe uncorrected primary valvular disease
  5. * Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
  6. * Systolic BP \< 100 mmHg, or symptomatic hypotension within the past 24 hours
  7. * 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
  8. * Type 1 diabetes mellitus
  9. * Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
  10. * 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
  11. * Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
  12. * Treatment with strong or moderate CYP3A4 inhibitor or inducer

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Alexander City, Alabama, 35010
United States
Research Site
Birmingham, Alabama, 35209
United States
Research Site
Fairhope, Alabama, 36532
United States
Research Site
Huntsville, Alabama, 35801
United States
Research Site
Little Rock, Arkansas, 72205
United States
Research Site
Beverly Hills, California, 90211
United States
Research Site
Encinitas, California, 92024
United States
Research Site
Los Angeles, California, 90073
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Orange, California, 92868
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Francisco, California, 94110
United States
Research Site
San Francisco, California, 94121
United States
Research Site
Santa Ana, California, 92704
United States
Research Site
Thousand Oaks, California, 91360
United States
Research Site
Vista, California, 92081
United States
Research Site
West Hills, California, 91307
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Wheat Ridge, Colorado, 80033
United States
Research Site
Altamonte Springs, Florida, 32701
United States
Research Site
Clearwater, Florida, 33756
United States
Research Site
Gainesville, Florida, 32610
United States
Research Site
Jacksonville, Florida, 32209
United States
Research Site
Miami, Florida, 33133
United States
Research Site
Palm Beach Gardens, Florida, 33410
United States
Research Site
Pensacola, Florida, 32503
United States
Research Site
Safety Harbor, Florida, 34695
United States
Research Site
Saint Augustine, Florida, 32086
United States
Research Site
Atlanta, Georgia, 30303
United States
Research Site
Tucker, Georgia, 30084
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Hazel Crest, Illinois, 60429
United States
Research Site
North Chicago, Illinois, 60064
United States
Research Site
Elkhart, Indiana, 46514
United States
Research Site
Hammond, Indiana, 46324
United States
Research Site
Indianapolis, Indiana, 46237
United States
Research Site
Muncie, Indiana, 47303
United States
Research Site
Munster, Indiana, 46321
United States
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Richmond, Indiana, 47374
United States
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Wichita, Kansas, 67218
United States
Research Site
Wichita, Kansas, 67226
United States
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Louisville, Kentucky, 40202
United States
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Alexandria, Louisiana, 71301
United States
Research Site
Shreveport, Louisiana, 71105
United States
Research Site
Augusta, Maine, 04330
United States
Research Site
Rockville, Maryland, 20850
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Fall River, Massachusetts, 02721
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Dearborn, Michigan, 48126
United States
Research Site
Flint, Michigan, 48504
United States
Research Site
Ypsilanti, Michigan, 48197
United States
Research Site
Minneapolis, Minnesota, 55455
United States
Research Site
Saint Paul, Minnesota, 55102
United States
Research Site
Jackson, Mississippi, 39216
United States
Research Site
Columbia, Missouri, 65201
United States
Research Site
Kansas City, Missouri, 64128
United States
Research Site
Lincoln, Nebraska, 68506
United States
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North Las Vegas, Nevada, 89086
United States
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Somerset, New Jersey, 08873
United States
Research Site
Bronx, New York, 10455
United States
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Buffalo, New York, 14215
United States
Research Site
New Windsor, New York, 12553
United States
Research Site
New York, New York, 10029
United States
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Staten Island, New York, 10310
United States
Research Site
Stony Brook, New York, 11794
United States
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Chapel Hill, North Carolina, 27517
United States
Research Site
Charlotte, North Carolina, 28204
United States
Research Site
Durham, North Carolina, 27710
United States
Research Site
Greensboro, North Carolina, 27405
United States
Research Site
Pinehurst, North Carolina, 28374
United States
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Wilmington, North Carolina, 28401
United States
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Cincinnati, Ohio, 45267
United States
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Maumee, Ohio, 43537
United States
Research Site
Springfield, Ohio, 45504
United States
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Oklahoma City, Oklahoma, 73102
United States
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Abington, Pennsylvania, 19001
United States
Research Site
Camp Hill, Pennsylvania, 17011
United States
Research Site
Hershey, Pennsylvania, 17033
United States
Research Site
Horsham, Pennsylvania, 19044
United States
Research Site
Providence, Rhode Island, 02908
United States
Research Site
Anderson, South Carolina, 29621
United States
Research Site
Charleston, South Carolina, 29401
United States
Research Site
Charleston, South Carolina, 29425
United States
Research Site
Lancaster, South Carolina, 29720
United States
Research Site
Rapid City, South Dakota, 57701
United States
Research Site
Jackson, Tennessee, 38305
United States
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Knoxville, Tennessee, 37916
United States
Research Site
Memphis, Tennessee, 38120
United States
Research Site
Memphis, Tennessee, 38128
United States
Research Site
Nashville, Tennessee, 37212
United States
Research Site
Tullahoma, Tennessee, 37388
United States
Research Site
Allen, Texas, 75013
United States
Research Site
Amarillo, Texas, 79106
United States
Research Site
Amarillo, Texas, 79121
United States
Research Site
Cypress, Texas, 77429
United States
Research Site
Dallas, Texas, 75216
United States
Research Site
Dallas, Texas, 75390
United States
Research Site
El Paso, Texas, 79905
United States
Research Site
Houston, Texas, 77002
United States
Research Site
Houston, Texas, 77025
United States
Research Site
Katy, Texas, 77493
United States
Research Site
Mansfield, Texas, 76063
United States
Research Site
McKinney, Texas, 75071
United States
Research Site
Odessa, Texas, 79761
United States
Research Site
Pearland, Texas, 77584
United States
Research Site
Sherman, Texas, 75092
United States
Research Site
Salt Lake City, Utah, 84107
United States
Research Site
Salt Lake City, Utah, 84148
United States
Research Site
Falls Church, Virginia, 22042
United States
Research Site
Newport News, Virginia, 23606
United States
Research Site
Seattle, Washington, 98101
United States
Research Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-12
Study Completion Date2027-06-11

Study Record Updates

Study Start Date2024-04-12
Study Completion Date2027-06-11

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure and Impaired Kidney Function