Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
NCT ID: NCT05180773
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2022-07-27
2028-12-31
Brief Summary
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Detailed Description
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Primary analysis will compare LVEF at 6 months post entry in the women receiving standard therapy plus bromocriptine to those on standard therapy plus placebo (controlling for initial baseline LVEF). Secondary endpoints will analyze the LVEF in both treatment groups at 12 months post randomization. In addition, subjects will be followed for up to 3 years post randomization and survival free from a major event (cardiac transplantation or durable LVAD implantation) and survival free from heart failure hospitalization will be compared by treatment group.
The benefits of bromocriptine are theoretically related to suppression of prolactin secretion. Breastfeeding increases prolactin levels, and whether continued breastfeeding will impact myocardial recovery in women with peripartum cardiomyopathy remains unknown. As bromocriptine prevents breastfeeding, women who want to continue breastfeeding are excluded from the randomized trial. 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 standard therapy with no additional intervention 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.
Blood will be obtained at entry for DNA banking, and analysis of serum, and whole blood RNA . Additional serum and whole blood RNA will be banked at 1-, 3-, and 6-months post randomization. This investigation will evaluate the impact of bromocriptine therapy on the levels of intact 23 kilodalton (kDa) prolactin and the 16 kDa prolactin fragment, as well as microRNA (miR) 146a. The biomarker analysis will also be performed in the observational cohort of women excluded due to continued breast feeding. The impact of these biomarkers on outcomes in both the treatment and control groups as well as the observational cohort excluded due to breastfeeding will be examined.
A core laboratory will analyze all echocardiograms. In addition to quantifying the LVEF at entry, 6 months and 12 months post entry, the core will evaluate global longitudinal strain (LGS) and remodeling (LV volumes) at entry as predictors of outcome and drug response. They will also evaluate the impact of therapy on LGS and LV volumes at 6- and 12-months post randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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),
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.
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.
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),
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Post-delivery and within the first 5 months post-partum.
3. Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial
4. Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
5. Age \> or = 18.
Exclusion Criteria
2. Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF.
3. Postpartum women currently breastfeeding and planning to continue.
4. Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test)
5. Previous cardiac transplant
6. Current durable LVAD support
7. Currently requiring support with extracorporeal membrane oxygenation (ECMO)
8. Current history of alcohol or drug abuse
9. Chemotherapy or chest radiation within 5 years of enrollment
10. Evidence of ongoing bacterial septicemia
11. Medical, social or psychiatric condition which limit the ability to comply with follow-up.
18 Years
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Dennis M. McNamara, MD, MS
OTHER
Responsible Party
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Dennis M. McNamara, MD, MS
Professor
Principal Investigators
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Dennis McNamara
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hossain
Role: backup
References
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Quesada O, Scantlebury DC, Briller JE, Michos ED, Aggarwal NR. Markers of Cardiovascular Risk Associated with Pregnancy. Curr Cardiol Rep. 2023 Feb;25(2):77-87. doi: 10.1007/s11886-022-01830-1. Epub 2023 Feb 6.
Briller JE. Echocardiographic Screening in Hypertensive Pregnancy Disorders: Probing the Window of Opportunity. J Am Coll Cardiol. 2022 Oct 11;80(15):1477-1479. doi: 10.1016/j.jacc.2022.08.717. No abstract available.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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STUDY21090058
Identifier Type: -
Identifier Source: org_study_id
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