Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

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.

Conditions

Peripartum Cardiomyopathy, Postpartum

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Study Overview

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Study Details

Study overview

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.

Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Condition
Peripartum Cardiomyopathy, Postpartum
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham, Birmingham, Alabama, United States, 35205

Tucson

University of Arizona Sarver Heart Center, Tucson, Arizona, United States, 85724

La Jolla

University of California San Diego, La Jolla, California, United States, 92037-7411

Los Angeles

Keck School of Medicine of USC, Los Angeles, California, United States, 90033

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Orange

University of California Irvine Health, Orange, California, United States, 92868

Stanford

Stanford University, Stanford, California, United States, 94305

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Presentation with a new diagnosis of peripartum cardiomyopathy
  • 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.
  • 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. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dennis M. McNamara, MD, MS,

Dennis McNamara, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2028-12-31