Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

PHASE4RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

July 27, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2028

Conditions
Peripartum Cardiomyopathy, Postpartum
Interventions
DRUG

Bromocriptine

Bromocriptine 2.5 mg one tablet by mouth twice daily for 2 weeks then once daily for 6 weeks. Subjects not on anticoagulation at the time of entry will also receive rivaroxaban 10 mg tablets once daily for 8 weeks while on bromocriptine.

DRUG

Placebo

Placebo one tablet by mouth twice daily for 2 weeks then once daily for 6 weeks. Subjects who are not on anticoagulation will not receive rivaroxaban but will receive a second placebo once daily for 8 weeks while on study drug.

DRUG

Guideline Directed Medical Therapy for Heart Failure (GDMT)

GDMT will potentially include angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor antagonists (ARB), angiotensin receptor blocker-neprilysin inhibitors (ARNI), beta adrenergic receptor antagonists (beta blockers) , Mineralocorticoid receptor antagonists (MRA), sodium-glucose cotransporter-2 inhibitors (SGLT2i),

DRUG

Rivaroxaban

Subjects not on anticoagulation clinically who are randomized to bromocriptine will receive rivaroxaban 10 mg tablets once tablet by mouth daily for 8 weeks while on bromocriptine.

DRUG

Second Placebo

Subjects not on anticoagulation clinically who are randomized to placebo (rather than bromocriptine) will receive a second placebo one tablet by mouth daily for 8 weeks.

Trial Locations (64)

10022

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Mount Sinai Hospital, New York

10032

RECRUITING

Columbia University Irving Medical Center, New York

10461

RECRUITING

Albert Einstein College of Medicine/ Montefiore Medical Center, The Bronx

11794

RECRUITING

Stony Brook Medicine, Stony Brook

14642

RECRUITING

University of Rochester, Rochester

15237

RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

17033

RECRUITING

Penn State Hershey Medical Center, Hershey

18105

WITHDRAWN

Lehigh Valley Health Network, Allentown

19104

RECRUITING

University of Pennsylvania, Philadelphia

19140

RECRUITING

Temple Heart and Vascular Institute, Philadelphia

21201

RECRUITING

University of Maryland Medical Center, Baltimore, Baltimore

21287

RECRUITING

Johns Hopkins University, Baltimore

22031

RECRUITING

Inova Healthcare Services, Fairfax

22908

RECRUITING

University of Virginia, Charlottesville

23298

RECRUITING

Virginia Commonwealth University, Richmond

23507

RECRUITING

Old Dominion University, Norfolk

28204

RECRUITING

Atrium Health Sanger Heart and Vascular Institute, Charlotte

29425

RECRUITING

Medical University of South Carolina, Charleston

30322

RECRUITING

Emory University, Atlanta

32216

RECRUITING

Mayo Clinic, Florida, Jacksonville

32608

RECRUITING

University of Florida, Gainesville

33606

RECRUITING

University of South Florida, Tampa

35205

RECRUITING

University of Alabama Birmingham, Birmingham

37232

RECRUITING

Vanderbilt, Nashville

38138

RECRUITING

Stern Cardiovascular Foundation, Inc, Germantown

40536

RECRUITING

University of Kentucky, Gill Heart & Vascular Institute, Lexington

44106

RECRUITING

University Hospitals, Cleveland Medical Center, Cleveland

44195

RECRUITING

Cleveland Clinic, Cleveland

46202

RECRUITING

Indiana University/Indiana University Health, Indianapolis

46260

RECRUITING

Ascension St. Vincent Heart Center, Indianapolis

48109

RECRUITING

University of Michigan, Ann Arbor

48202

RECRUITING

Henry Ford Health System, Detroit

52242

RECRUITING

University of Iowa Hospitals and Clinic, Iowa City

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

53792

RECRUITING

University of Wisconsin Madison, Madison

55407

RECRUITING

Minneapolis Heart Institute Foundation, Minneapolis

55455

RECRUITING

University of Minnesota, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester, Rochester

60611

RECRUITING

Northwestern University, Chicago

60612

RECRUITING

University of Illinois Health Heart Center, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

64154

RECRUITING

Saint Luke's Hospital of Kansas City, Kansas City

65201

RECRUITING

Karen L Florio, MD, Columbia

71103

RECRUITING

Louisiana State University, Shreveport

73104

RECRUITING

Oklahoma university Health Science Center, Oklahoma City

77030

RECRUITING

Baylor College of Medicine, Houston

78229

WITHDRAWN

University of Texas Health San Antonio, San Antonio

80045

RECRUITING

University of Colorado Anschutz Medical Campus, Aurora

84107

RECRUITING

Intermountain Medical Center, Murray

85724

RECRUITING

University of Arizona Sarver Heart Center, Tucson

90033

RECRUITING

Keck School of Medicine of USC, Los Angeles

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

92868

RECRUITING

University of California Irvine Health, Orange

94305

RECRUITING

Stanford University, Stanford

98195

RECRUITING

University of Washington Medical Center, Seattle

92037-7411

RECRUITING

University of California San Diego, La Jolla

06106

RECRUITING

Hartford Hospital, Hartford

06520

RECRUITING

Yale University, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham and Women's Hospital, Boston

02903

RECRUITING

Rhode Island Hospital, Providence

75390-8830

WITHDRAWN

UT Southern Medical Center, Dallas

05401

RECRUITING

University of Vermont Medical Center, Burlington

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Dennis M. McNamara, MD, MS

OTHER