Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Peripartum Cardiomyopathy, Postpartum

In brief

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.

Key facts

Study ID

NCT05180773

Run by

Dennis M. McNamara, MD, MS

People needed

250

Starts

2022-07-27

Expected to finish

2028-12-31

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)
• Refractory hypertension (Systolic >160 or Diastolic > 95) either at the time of enrollment or at the time of the qualifying LVEF.
• Postpartum women currently breastfeeding and planning to continue.
• Evidence of coronary artery disease (>50% stenosis of major epicardial vessel or positive non-invasive stress test)
• Previous cardiac transplant
• Current durable LVAD support
• Currently requiring support with extracorporeal membrane oxygenation (ECMO)
• Current history of alcohol or drug abuse
• Chemotherapy or chest radiation within 5 years of enrollment
• Evidence of ongoing bacterial septicemia
• Medical, social or psychiatric condition which limit the ability to comply with follow-up.

Where it is running

• University of Arizona Sarver Heart Center — Tucson, Arizona, United States (enrolling)
• University of California San Diego — La Jolla, California, United States (enrolling)
• Keck School of Medicine of USC — Los Angeles, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of California Irvine Health — Orange, California, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Mayo Clinic, Florida — Jacksonville, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Illinois Health Heart Center — Chicago, Illinois, United States (enrolling)
• Indiana University/Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• Ascension St. Vincent Heart Center — Indianapolis, Indiana, United States (enrolling)
• University of Iowa Hospitals and Clinic — Iowa City, Iowa, United States (enrolling)
• University of Kentucky, Gill Heart & Vascular Institute — Lexington, Kentucky, United States (enrolling)
• Louisiana State University — Shreveport, Louisiana, United States (enrolling)
• University of Maryland Medical Center, Baltimore — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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