Recruiting

BromocriptineImpact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Sponsor:

Dennis M. McNamara, MD, MS

Code:

NCT05180773

Conditions

Peripartum Cardiomyopathy, Postpartum

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bromocriptine

Placebo

Guideline Directed Medical Therapy for Heart Failure (GDMT)

Rivaroxaban

Second Placebo

Study Details

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

Study ID

NCT05180773

Start date

Jul 27, 2022

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bromocriptine Treatment Arm

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.

placebo comparator: Placebo Arm

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.

other: Breastfeeding Observational Cohort

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.

Interventions

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.

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.

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),

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.

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.

Primary outcome measure

Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Dennis McNamara, MD

412-802-3131 mcnamaradm@upmc.edu

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

LaTangellia Walker

(205) 934-4225 latangelliadwalker@uabmc.edu

Nancy Saxon

(205) 934-1616 nbsaxon@uabmc.edu

Principal Investigator:

Rachel Sinkey, MD

University of Arizona Sarver Heart Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Lizzette Cruz

520-626-2471 marquez@shc.arizona.edu

Principal Investigator:

Elizabeth Juneman, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92037-7411

Contacts

Rachel Han

rah015@health.ucsd.edu

Principal Investigator:

Hilary Shapiro, MD

Keck School of Medicine of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Jorge Caro

(323) 382-7646 jorge.caro@med.usc.edu

Principal Investigator:

Uri Elkayam, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Odette Chida Ibarra

310-423-9459 odette.chidaibarra@cshs.org

Principal Investigator:

Janet Wei, MD

University of California Irvine Health

Recruiting

Orange, California, United States, 92868

Contacts

Linh Huỳnh, MPH

(714) 456-6155 plhuynh@hs.uci.edu

Principal Investigator:

Afshan Hameed, MD

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Tamara Bazouzi

(650) 723-7024 bazouzit@stanford.edu

Principal Investigator:

Abha Khandelwal, M.D.

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jamie Demmitt, BA

720-808-1989 jamie.demmitt@cuanschutz.edu

Principal Investigator:

Michael Rosenberg, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Khadija El Aoudi

860-972-3167 Khadija.ElAoudi@hhchealth.org

Principal Investigator:

Jennifer Bell, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Cinthia S De Freitas

(203) 785-6315 cinthia.defreitas@yale.edu

Principal Investigator:

Sara Tabtabai, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

David Solares

(689) 246-8106 David.Solares@medicine.ufl.edu

Vanessa Holway Scheuble

(386) 365-0203 Vanessa.Scheuble@medicine.ufl.edu

Principal Investigator:

Alex Parker, MD

Mayo Clinic, Florida

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Jena Hayes

(904) 953-4143 hayes.jena@mayo.edu

Ann Dunshee

(904) 953-5102 Dunshee.Ann@mayo.edu

Principal Investigator:

Demilade Adedinsewo, MD, MPH

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Amanda McNamara

(813) 396-2729 alett1@usf.edu

Laura Cordero

(813) 716-0758 lauracordero@usf.edu

Principal Investigator:

Daniela Crousillat, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Eisha Udeshi

404-712-1961 eudeshi@emory.edu

Nino Kavtaradze

(404) 712-0502 nkavtar@emory.edu

Principal Investigator:

Kunal Bhatt, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kathleen Flores

(312) 503-1069 Kathleen.Flores@northwestern.edu

Principal Investigator:

Priya Freaney, MD

University of Illinois Health Heart Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Muriel Chen

312-355-1861 yining@uic.edu

Principal Investigator:

Joan Briller, MD

Indiana University/Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Srdjan Kurbalija

317 962 9904 skurbalija@iuhealth.org

Principal Investigator:

Roopa Rao, MD

Ascension St. Vincent Heart Center

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Anne Renick

317-338-6152 anne.renick@ascension.org

Regina Margiotti

317-338-6151 RAMARGIO@ascension.org

Principal Investigator:

Mary Walsh, M.D.

University of Iowa Hospitals and Clinic

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Traci Parks

(319) 353-5236 traci-parks@uiowa.edu

Page Scovel

(319) 353-5247 page-scovel@uiowa.edu

Principal Investigator:

Linda Cadaret, MD

University of Kentucky, Gill Heart & Vascular Institute

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Jennifer Isaacs

859-323-4738 Jennifer.isaacs@uky.edu

Travis Sexton

(859) 323-1082 trsext2@uky.edu

Principal Investigator:

Navin Rajagopalan, M.D.

Louisiana State University

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Monicah Jepkemboi

318-675-8882 monicah.jepkemboi@lsuhs.edu

Principal Investigator:

Kalgi Modi, MD

University of Maryland Medical Center, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Caitlin Hearn

(410) 328-8790 chearn@som.umaryland.edu

Principal Investigator:

Lisa Forbess, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Yavette Goldsborough

410-614-4449 ygoldsb1@jhmi.edu

Principal Investigator:

Nisha Gilotra, M.D.

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Monica Duan

(781) 690-4657 mduan2@mgb.org

Principal Investigator:

Nandita S. Scott, MD FACC

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Audrey Yun

(714) 833-2524 ayun1@bwh.harvard.edu

Mariam Markabani

(313) 329-3133 mmarkabani@bwh.harvard.edu

Principal Investigator:

Michael Givertz, M.D.

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sharada Lanka

(734) 232-0550 slanka@med.umich.edu

Principal Investigator:

Melinda Davis, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Jodi Carter

313-916-3613 jcarte23@hfhs.org

Principal Investigator:

Ryhm Radjef, M.D.

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Sarah Schwager

(612) 863-6257 Sarah.Schwager@allina.com

Molly Fuller

(612) 863-7493 Molly.Fuller@allina.com

Principal Investigator:

Retu Saxena, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Melanie Farinella

(612) 626-4611 crawl027@umn.edu

Principal Investigator:

Bhavadharini Ramu, MD

Mayo Clinic, Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lezlie Peterson

(507) 255-2029 Johnson.Lezlie@mayo.edu

Kayla Syring

(507) 284-4253 Syring.Kayla@mayo.edu

Principal Investigator:

Kathleen Young, MD

Karen L Florio, MD

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Kaycee Mackanos

(573) 817-3386 kmznn@umsystem.edu

Principal Investigator:

Karen L Florio, MD

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Rosann Gans, RN

(816) 932-6122 rgans@saint-lukes.org

Principal Investigator:

Anna Grodzinsky, MD,MSc

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Annie Dirks

(314) 454-8711 aplatts@wustl.edu

Lesley Alexander

(314) 273-1425 alesley@wustl.edu

Principal Investigator:

Gregory Ewald, M.D.

NYU Langone Health

Recruiting

New York, New York, United States, 10022

Contacts

Lucia Muzzarelli

(646) 754-2760 Lucia.Muzzarelli@nyulangone.org

Principal Investigator:

Christina Penfield, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Lovelyne Julien

845-659-1926 lovelyn.julien@mountsinai.org

Tiffany Soto

(212) 241-2210 tiffany.soto@mssm.edu

Principal Investigator:

Anuradha Lala-Trindade, MD

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Hadley Reinke

(952) 297-5036 hnr2111@cumc.columbia.edu

Jessica Idumonyi

(212) 305-1429 joi2102@cumc.columbia.edu

Principal Investigator:

Jennifer Haythe, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Lori Caufield, RN BSN CCRC

585-273-4956 lori_caufield@urmc.rochester.edu

Principal Investigator:

Jeffrey Alexis, MD

Stony Brook Medicine

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Uzma Usmani

(631) 444-7339 Uzma.Usmani@stonybrookmedicine.edu

Principal Investigator:

Hal Skopicki, MD

Albert Einstein College of Medicine/ Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Contacts

Vanya Prasad

(718) 920-2010 vprasad@montefiore.org

Principal Investigator:

Sandhya Murthy, M.D.

Atrium Health Sanger Heart and Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Sangeetha Dinakaran

(704) 446-2096 Sangeetha.dinakaran@atriumhealth.org

Principal Investigator:

Catarina Canha, MD

University Hospitals, Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Emily Mullenax

(216) 844-3852 Emily.Mullenax@UHhospitals.org

Principal Investigator:

Chantal ElAmm, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Barbara Gus

(216) 445-6552 gusb@ccf.org

Principal Investigator:

Karlee Hoffman, MD

Oklahoma university Health Science Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Natalie Feland

(405) 271-3480 natalie-feland@ouhsc.edu

Principal Investigator:

Tarun Dasari, M.D.

Penn State Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Katie Loffredo

717-531-6855 kloffredo@pennstatehealth.psu.edu

Veronica Bausher

(717) 531-6510 vbausher@pennstatehealth.psu.edu

Principal Investigator:

John P. Boehmer, M.D.

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alavi Hossain

(215) 220-9580 Alavi.Hossain@Pennmedicine.upenn.edu

Principal Investigator:

Jennifer Lewey, MD

Temple Heart and Vascular Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Jennie Wong

215 707-0061 jennie.wong@tuhs.temple.edu

Principal Investigator:

Deborah Crabbe, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Dennis McNamara, MD

412-802-3131 mcnamaradm@upmc.edu

Donna Simpson, CRNP, MPH

412-692-3522 simpsondm@upmc.edu

Principal Investigator:

Dennis McNamara, MD

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Kelly Franchetti, RN

401-444-9828 kfranchetti@lifespan.org

Principal Investigator:

Athena Poppas, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Virginia Theodorof

(843) 876-9078 theodoro@musc.edu

Olivia Washington

(843) 876-5785 washoliv@musc.edu

Principal Investigator:

Stephanie Gaydos, MD

Stern Cardiovascular Foundation, Inc

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Denise Peeler

(901) 271-4163 denise.peeler@sterncardio.com

Kari Fondren

(901) 271-4062 kari.fondren@sterncardio.com

Principal Investigator:

Frank McGrew, MD

Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Olivia Patridge

olivia.h.patridge@vumc.org

Principal Investigator:

Julie Damp, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Sandra Pena

(832)- 826-2806 sandra.pena@bcm.edu

Principal Investigator:

Christopher Broda

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Morgan McClure

(801) 507-9459 morgan.mcclure@imail.org

Principal Investigator:

Rami Alharethi, M.D.

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Meghan Sesera, RN

802-847-4746 meghan.sesera@uvmhealth.org

Michaelanne Rowen

(802) 847-4746 Michaelanne.Rowen@uvmhealth.org

Principal Investigator:

Friederike Keating, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Frankie Shelton

(434) 982-1058 ZSB5KR@uvahealth.org

Caroline Flournoy

4349246104 clf4w@uvahealth.org

Principal Investigator:

Patricia Rodriguez-Lozano M.D, MD

Inova Healthcare Services

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Joanne Wotring

571-472-2919 joanne.wotring@inova.org

Principal Investigator:

Garima Sharma, MD

Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Kristin Ayers

757-446-0529 ayerskl@evms.edu

Principal Investigator:

Gloria Too, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Melissa Sears

(804) 828-1601 melissa.sears@vcuhealth.org

Principal Investigator:

Saima Shikari-Dossaji, MD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Adele Stefanowicz

206-616-6768 amstef99@cardiology.washington.edu

Principal Investigator:

April Stempien-Otero, MD, FACC

University of Wisconsin Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Karen Olson

(608) 263-1544 kjolson@medicine.wisc.edu

Principal Investigator:

Allexa Licon, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Faith Boemer

(414) 955-6854 fboerner@mcw.edu

Principal Investigator:

Scott Cohen, MD

More Information

Sponsor

Dennis M. McNamara, MD, MS

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dennis M. McNamara, MD, MS on 2026-08-10.