RECRUITING

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

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Conditions

Peripartum Cardiomyopathy, Postpartum

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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

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)

Quick Facts

Study Start:2022-07-27
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05180773

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
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Presentation with a new diagnosis of peripartum cardiomyopathy
  2. 2. Post-delivery and within the first 5 months post-partum.
  3. 3. Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial
  4. 4. Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
  5. 5. Age \> or = 18.
  1. 1. Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum cardiomyopathy with complete recovery and a documented LVEF \> 0.55 prior to or in early pregnancy)
  2. 2. Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF.
  3. 3. Postpartum women currently breastfeeding and planning to continue.
  4. 4. Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test)
  5. 5. Previous cardiac transplant
  6. 6. Current durable LVAD support
  7. 7. Currently requiring support with extracorporeal membrane oxygenation (ECMO)
  8. 8. Current history of alcohol or drug abuse
  9. 9. Chemotherapy or chest radiation within 5 years of enrollment
  10. 10. Evidence of ongoing bacterial septicemia
  11. 11. Medical, social or psychiatric condition which limit the ability to comply with follow-up.

Contacts and Locations

Study Contact

Dennis McNamara, MD
CONTACT
412-802-3131
mcnamaradm@upmc.edu

Principal Investigator

Dennis McNamara
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35205
United States
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724
United States
University of California San Diego
La Jolla, California, 92037-7411
United States
Keck School of Medicine of USC
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California Irvine Health
Orange, California, 92868
United States
Stanford University
Stanford, California, 94305
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06520
United States
University of Florida
Gainesville, Florida, 32608
United States
Mayo Clinic, Florida
Jacksonville, Florida, 32216
United States
University of South Florida
Tampa, Florida, 33606
United States
Emory University
Atlanta, Georgia, 30322
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Illinois Health Heart Center
Chicago, Illinois, 60612
United States
Indiana University/Indiana University Health
Indianapolis, Indiana, 46202
United States
Ascension St. Vincent Heart Center
Indianapolis, Indiana, 46260
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Iowa Hospitals and Clinic
Iowa City, Iowa, 52242
United States
University of Kentucky, Gill Heart & Vascular Institute
Lexington, Kentucky, 40536
United States
Louisiana State University
Shreveport, Louisiana, 71103
United States
University of Maryland Medical Center, Baltimore
Baltimore, Maryland, 21201
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
United States
Karen L Florio, MD
Columbia, Missouri, 65201
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64154
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Albert Einstein College of Medicine/ Montefiore Medical Center
Bronx, New York, 10461
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
University of Rochester
Rochester, New York, 14642
United States
Stony Brook Medicine
Stony Brook, New York, 11794
United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oklahoma university Health Science Center
Oklahoma City, Oklahoma, 73104
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Temple Heart and Vascular Institute
Philadelphia, Pennsylvania, 19140
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15237
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt
Nashville, Tennessee, 37232
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Texas Health San Antonio
San Antonio, Texas, 78229
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Dennis M. McNamara, MD, MS

  • Dennis McNamara, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2022-07-27
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2022-07-27
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Peripartum Cardiomyopathy, Postpartum