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Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Sponsor: Dennis M. McNamara, MD, MS
Summary
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort.
Official title: Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2022-07-27
Completion Date
2028-12-31
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
Bromocriptine
Bromocriptine 2.5 mg one tablet by mouth twice daily for 2 weeks then once daily for 6 weeks. Subjects not on anticoagulation at the time of entry will also receive rivaroxaban 10 mg tablets once daily for 8 weeks while on bromocriptine.
Placebo
Placebo one tablet by mouth twice daily for 2 weeks then once daily for 6 weeks. Subjects who are not on anticoagulation will not receive rivaroxaban but will receive a second placebo once daily for 8 weeks while on study drug.
Guideline Directed Medical Therapy for Heart Failure (GDMT)
GDMT will potentially include angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor antagonists (ARB), angiotensin receptor blocker-neprilysin inhibitors (ARNI), beta adrenergic receptor antagonists (beta blockers) , Mineralocorticoid receptor antagonists (MRA), sodium-glucose cotransporter-2 inhibitors (SGLT2i),
Rivaroxaban
Subjects not on anticoagulation clinically who are randomized to bromocriptine will receive rivaroxaban 10 mg tablets once tablet by mouth daily for 8 weeks while on bromocriptine.
Second Placebo
Subjects not on anticoagulation clinically who are randomized to placebo (rather than bromocriptine) will receive a second placebo one tablet by mouth daily for 8 weeks.
Locations (64)
University of Alabama Birmingham
Birmingham, Alabama, United States
University of Arizona Sarver Heart Center
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Irvine Health
Orange, California, United States
Stanford University
Stanford, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic, Florida
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois Health Heart Center
Chicago, Illinois, United States
Indiana University/Indiana University Health
Indianapolis, Indiana, United States
Ascension St. Vincent Heart Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinic
Iowa City, Iowa, United States
University of Kentucky, Gill Heart & Vascular Institute
Lexington, Kentucky, United States
Louisiana State University
Shreveport, Louisiana, United States
University of Maryland Medical Center, Baltimore
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Karen L Florio, MD
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Albert Einstein College of Medicine/ Montefiore Medical Center
The Bronx, New York, United States
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma university Health Science Center
Oklahoma City, Oklahoma, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple Heart and Vascular Institute
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
UT Southern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Healthcare Services
Fairfax, Virginia, United States
Old Dominion University
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States