Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)
Who is this study for? Patients with peripartum cardiomyopathy
What treatments are being studied? Bromocriptine+Guideline Directed Medical Therapy for Heart Failure+Rivaroxaban
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Presentation with a new diagnosis of peripartum cardiomyopathy
• Post-delivery and within the first 5 months post-partum.
• Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial
• Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
• Age \> or = 18.
Locations
United States
Alabama
University of Alabama Birmingham
RECRUITING
Birmingham
Arizona
University of Arizona Sarver Heart Center
RECRUITING
Tucson
California
University of California San Diego
RECRUITING
La Jolla
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Keck School of Medicine of USC
RECRUITING
Los Angeles
University of California Irvine Health
RECRUITING
Orange
Stanford University
RECRUITING
Stanford
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Florida
University of Florida
RECRUITING
Gainesville
Mayo Clinic, Florida
RECRUITING
Jacksonville
University of South Florida
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa Hospitals and Clinic
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
University of Illinois Health Heart Center
RECRUITING
Chicago
Indiana
Ascension St. Vincent Heart Center
RECRUITING
Indianapolis
Indiana University/Indiana University Health
RECRUITING
Indianapolis
Kentucky
University of Kentucky, Gill Heart & Vascular Institute
RECRUITING
Lexington
Louisiana
Louisiana State University
RECRUITING
Shreveport
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
University of Maryland Medical Center, Baltimore
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic, Rochester
RECRUITING
Rochester
Missouri
Karen L Florio, MD
RECRUITING
Columbia
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Atrium Health Sanger Heart and Vascular Institute
RECRUITING
Charlotte
New York
Columbia University Irving Medical Center
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Stony Brook Medicine
RECRUITING
Stony Brook
Albert Einstein College of Medicine/ Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals, Cleveland Medical Center
RECRUITING
Cleveland
Oklahoma
Oklahoma university Health Science Center
RECRUITING
Oklahoma City
Pennsylvania
Lehigh Valley Health Network
WITHDRAWN
Allentown
Penn State Hershey Medical Center
RECRUITING
Hershey
Temple Heart and Vascular Institute
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Stern Cardiovascular Foundation, Inc
RECRUITING
Germantown
Vanderbilt
RECRUITING
Nashville
Texas
UT Southern Medical Center
WITHDRAWN
Dallas
Baylor College of Medicine
RECRUITING
Houston
University of Texas Health San Antonio
WITHDRAWN
San Antonio
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
University of Virginia
RECRUITING
Charlottesville
Inova Healthcare Services
RECRUITING
Fairfax
Old Dominion University
RECRUITING
Norfolk
Virginia Commonwealth University
RECRUITING
Richmond
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Washington
University of Washington Medical Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin Madison
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Dennis McNamara, MD
mcnamaradm@upmc.edu
412-802-3131
Time Frame
Start Date: 2022-07-27
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 250
Treatments
Active_comparator: Bromocriptine Treatment Arm
100 Women in the Treatment Arm will receive guideline directed medical therapy for heart failure plus 8 weeks of bromocriptine administered orally as 2.5 mg twice daily for 2 weeks then 2.5mg once daily for 6 weeks. Women not on clinical anticoagulation will also receive prophylactic anticoagulation with rivaroxaban 10 mg once daily for 8 weeks while on bromocriptine.
Placebo_comparator: Placebo Arm
100 Women in the Placebo Arm will receive guideline directed medical therapy for heart failure plus 8 weeks of a placebo administered orally twice daily for 2 weeks then once daily for 6 weeks. Women not on clinical anticoagulation will not receive rivaroxaban but will instead receive a second placebo for 8 weeks.
Other: Breastfeeding Observational Cohort
Up to 50 women meeting all other criteria but excluded from REBIRTH due to an intent to continue to breastfeed will be enrolled in an observational cohort. They will receive guideline directed medical therapy with no additional interventions and will have the same follow up and assessment of myocardial recovery by echocardiogram at 6 and 12 months post entry as women in the randomized trial.
Related Therapeutic Areas
Sponsors
Leads: Dennis M. McNamara, MD, MS
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)