Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

NCT05180773 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY21090058UG3HL153847
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 64

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography

  6 months

Secondary Outcomes (3)

• Left ventricular ejection fraction (LVEF) at 12 months post entry as determined by echocardiography

  12 months

• Survival free from cardiac transplantation or implantation of a durable left ventricular assist device (LVAD)

  3 years

• Survival free from heart failure hospitalization

  3 years

Other Outcomes (4)

• Global longitudinal strain (GLS) at 6 months post entry as determined by echocardiography

  6 months

• Global longitudinal strain (GLS) at 12 months post entry as determined by echocardiography

  12 months

• Left ventricular volumes at 6 months post entry as determined by echocardiography

  6 months

Study Arms (3)

Bromocriptine Treatment Arm

ACTIVE COMPARATOR

100 Women in the Treatment Arm will receive guideline directed medical therapy for heart failure plus 8 weeks of bromocriptine administered orally as 2.5 mg twice daily for 2 weeks then 2.5mg once daily for 6 weeks. Women not on clinical anticoagulation will also receive prophylactic anticoagulation with rivaroxaban 10 mg once daily for 8 weeks while on bromocriptine.

Drug: Bromocriptine; Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT); Drug: Rivaroxaban

Placebo Arm

PLACEBO COMPARATOR

100 Women in the Placebo Arm will receive guideline directed medical therapy for heart failure plus 8 weeks of a placebo administered orally twice daily for 2 weeks then once daily for 6 weeks. Women not on clinical anticoagulation will not receive rivaroxaban but will instead receive a second placebo for 8 weeks.

Drug: Placebo; Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT); Drug: Second Placebo

Breastfeeding Observational Cohort

OTHER

Up to 50 women meeting all other criteria but excluded from REBIRTH due to an intent to continue to breastfeed will be enrolled in an observational cohort. They will receive guideline directed medical therapy with no additional interventions and will have the same follow up and assessment of myocardial recovery by echocardiogram at 6 and 12 months post entry as women in the randomized trial.

Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT)

Interventions

Bromocriptine DRUG

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.

Also known as: Parlodel, Cycloset

Bromocriptine Treatment Arm

Placebo DRUG

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.

Placebo Arm

Guideline Directed Medical Therapy for Heart Failure (GDMT) DRUG

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),

Breastfeeding Observational Cohort; Bromocriptine Treatment Arm; Placebo Arm

Rivaroxaban DRUG

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.

Also known as: Xarelto

Bromocriptine Treatment Arm

Second Placebo DRUG

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.

Also known as: Placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women recently diagnosed with peripartum cardiomyopathy who are 18 years or older and are within 5 months of postpartum.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dennis M. McNamara, MD, MS: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (64)

University of Alabama Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724, United States

RECRUITING

University of California San Diego

La Jolla, California, 92037-7411, United States

RECRUITING

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California Irvine Health

Orange, California, 92868, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Mayo Clinic, Florida

Jacksonville, Florida, 32216, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois Health Heart Center

Chicago, Illinois, 60612, United States

RECRUITING

Indiana University/Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Ascension St. Vincent Heart Center

Indianapolis, Indiana, 46260, United States

RECRUITING

University of Iowa Hospitals and Clinic

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky, Gill Heart & Vascular Institute

Lexington, Kentucky, 40536, United States

RECRUITING

Louisiana State University

Shreveport, Louisiana, 71103, United States

RECRUITING

University of Maryland Medical Center, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Karen L Florio, MD

Columbia, Missouri, 65201, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64154, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

NYU Langone Health

New York, New York, 10022, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook Medicine

Stony Brook, New York, 11794, United States

RECRUITING

Albert Einstein College of Medicine/ Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Atrium Health Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Oklahoma university Health Science Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Lehigh Valley Health Network

Allentown, Pennsylvania, 18105, United States

WITHDRAWN

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Temple Heart and Vascular Institute

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Stern Cardiovascular Foundation, Inc

Germantown, Tennessee, 38138, United States

RECRUITING

Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

UT Southern Medical Center

Dallas, Texas, 75390-8830, United States

WITHDRAWN

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

WITHDRAWN

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Inova Healthcare Services

Fairfax, Virginia, 22031, United States

RECRUITING

Old Dominion University

Norfolk, Virginia, 23507, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (2)

• Quesada O, Scantlebury DC, Briller JE, Michos ED, Aggarwal NR. Markers of Cardiovascular Risk Associated with Pregnancy. Curr Cardiol Rep. 2023 Feb;25(2):77-87. doi: 10.1007/s11886-022-01830-1. Epub 2023 Feb 6.

  PMID: 36745273 DERIVED

• Briller JE. Echocardiographic Screening in Hypertensive Pregnancy Disorders: Probing the Window of Opportunity. J Am Coll Cardiol. 2022 Oct 11;80(15):1477-1479. doi: 10.1016/j.jacc.2022.08.717. No abstract available.

  PMID: 36202537 DERIVED

MeSH Terms

Conditions

Peripartum Cardiomyopathy

Interventions

Bromocriptine; Rivaroxaban

Condition Hierarchy (Ancestors)

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dennis McNamara

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis McNamara, MD

CONTACT

412-802-3131; mcnamaradm@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once consent is obtained the screening sheet will be submitted to the data coordinating center. This will be reviewed to ensure the subject meets criteria for randomization. Subjects will be randomized by the Data Coordinating Center (DCC).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 200 women meeting all inclusion and exclusion criterial will be randomized in a placebo controlled double blind investigation evaluating the impact of bromocriptine on outcomes for women newly diagnosed with peripartum cardiomyopathy. An additional 50 women in excluded from the trial due to an intent to continue breastfeeding but meeting all other criteria will be enrolled in an observational cohort. All women with receive standard medical care for peripartum cardiomyopathy and will be followed for up to three years.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 6, 2022
• Study Start: July 27, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-02

Locations

US (64)