RECRUITING
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Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
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
🗓️ Study Start (Actual) 27 July 2022
🗓️ Primary Completion (Estimated) 30 June 2026
✅ Study Completion (Estimated) 31 December 2028
👥 Enrollment (Estimated) 250
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Birmingham, Alabama, United States
📍 Tucson, Arizona, United States
📍 La Jolla, California, United States
📍 Los Angeles, California, United States
📍 Los Angeles, California, United States
📍 Orange, California, United States
📍 Stanford, California, United States
📍 Aurora, Colorado, United States
📍 New Haven, Connecticut, United States
📍 Gainesville, Florida, United States
📍 Jacksonville, Florida, United States
📍 Atlanta, Georgia, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Indianapolis, Indiana, United States
📍 Indianapolis, Indiana, United States
📍 Iowa City, Iowa, United States
📍 Lexington, Kentucky, United States
📍 Shreveport, Louisiana, United States
📍 Baltimore, Maryland, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Detroit, Michigan, United States
📍 Rochester, Minnesota, United States
📍 Columbia, Missouri, United States
📍 Kansas City, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Bronx, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Stony Brook, New York, United States
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Allentown, Pennsylvania, United States
📍 Hershey, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Providence, Rhode Island, United States
📍 Charleston, South Carolina, United States
📍 Nashville, Tennessee, United States
📍 Dallas, Texas, United States
📍 San Antonio, Texas, United States
📍 Murray, Utah, United States
📍 Burlington, Vermont, United States
📍 Charlottesville, Virginia, United States
📍 Richmond, Virginia, United States
📍 Seattle, Washington, United States
📍 Milwaukee, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion 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.

    Exclusion Criteria:

    • 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 N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 9 December 2021
  • First Submitted that Met QC Criteria 4 January 2022
  • First Posted 6 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 February 2024
  • Last Update Posted 12 February 2024
  • Last Verified February 2024
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