Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT05180773

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Led by Dennis M. McNamara, MD, MS · Updated on 2025-09-22

250

Participants Needed

64

Research Sites

335 weeks

Total Duration

On this page

Sponsors

D

Dennis M. McNamara, MD, MS

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • New diagnosis of peripartum cardiomyopathy
  • Within 5 months postpartum
  • LVEF of 0.40 or less within 4 weeks before consent for randomized trial
  • LVEF of 0.40 or less within 8 weeks before consent for breastfeeding cohort
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Previous cardiomyopathy, valvular disease or congenital heart disease (except women with prior peripartum cardiomyopathy fully recovered with LVEF > 0.55 before or early in pregnancy)
  • Uncontrolled high blood pressure (systolic >160 or diastolic >95) at enrollment or qualifying LVEF
  • Currently breastfeeding and planning to continue
  • Evidence of significant coronary artery disease (>50% stenosis or positive stress test)
  • Previous heart transplant
  • Current durable left ventricular assist device (LVAD) support
  • Need for extracorporeal membrane oxygenation (ECMO)
  • Current alcohol or drug abuse
  • Chemotherapy or chest radiation within past 5 years
  • Ongoing bacterial septicemia
  • Medical, social, or psychiatric issues limiting study follow-up compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 64 locations

1

University of Alabama Birmingham

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

University of Arizona Sarver Heart Center

Tucson, Arizona, United States, 85724

Actively Recruiting

3

University of California San Diego

La Jolla, California, United States, 92037-7411

Actively Recruiting

4

Keck School of Medicine of USC

Los Angeles, California, United States, 90033

Actively Recruiting

5

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

6

University of California Irvine Health

Orange, California, United States, 92868

Actively Recruiting

7

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

8

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

9

Hartford Hospital

Hartford, Connecticut, United States, 06106

Actively Recruiting

10

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

11

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

12

Mayo Clinic, Florida

Jacksonville, Florida, United States, 32216

Actively Recruiting

13

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

14

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

15

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

16

University of Illinois Health Heart Center

Chicago, Illinois, United States, 60612

Actively Recruiting

17

Indiana University/Indiana University Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

18

Ascension St. Vincent Heart Center

Indianapolis, Indiana, United States, 46260

Actively Recruiting

19

University of Iowa Hospitals and Clinic

Iowa City, Iowa, United States, 52242

Actively Recruiting

20

University of Kentucky, Gill Heart & Vascular Institute

Lexington, Kentucky, United States, 40536

Actively Recruiting

21

Louisiana State University

Shreveport, Louisiana, United States, 71103

Actively Recruiting

22

University of Maryland Medical Center, Baltimore

Baltimore, Maryland, United States, 21201

Actively Recruiting

23

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

24

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

25

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

26

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

27

Henry Ford Health System

Detroit, Michigan, United States, 48202

Actively Recruiting

28

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

29

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

30

Mayo Clinic, Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

31

Karen L Florio, MD

Columbia, Missouri, United States, 65201

Actively Recruiting

32

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States, 64154

Actively Recruiting

33

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

34

NYU Langone Health

New York, New York, United States, 10022

Actively Recruiting

35

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

36

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

37

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

38

Stony Brook Medicine

Stony Brook, New York, United States, 11794

Actively Recruiting

39

Albert Einstein College of Medicine/ Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

40

Atrium Health Sanger Heart and Vascular Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

41

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

42

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

43

Oklahoma university Health Science Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

44

Lehigh Valley Health Network

Allentown, Pennsylvania, United States, 18105

Withdrawn

45

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

46

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

47

Temple Heart and Vascular Institute

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

48

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15237

Actively Recruiting

49

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

50

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

51

Stern Cardiovascular Foundation, Inc

Germantown, Tennessee, United States, 38138

Actively Recruiting

52

Vanderbilt

Nashville, Tennessee, United States, 37232

Actively Recruiting

53

UT Southern Medical Center

Dallas, Texas, United States, 75390-8830

Withdrawn

54

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

55

University of Texas Health San Antonio

San Antonio, Texas, United States, 78229

Withdrawn

56

Intermountain Medical Center

Murray, Utah, United States, 84107

Actively Recruiting

57

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

58

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

59

Inova Healthcare Services

Fairfax, Virginia, United States, 22031

Actively Recruiting

60

Old Dominion University

Norfolk, Virginia, United States, 23507

Actively Recruiting

61

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

62

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

63

University of Wisconsin Madison

Madison, Wisconsin, United States, 53792

Actively Recruiting

64

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

D

Dennis McNamara, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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