AzTrials
AzTrials

Peripartum Cardiomyopathy, PostpartumPhase 4REBIRTHNCT05180773

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

A Phase 4 study testing Bromocriptine, Guideline Directed Medical Therapy for Heart Failure (GDMT) and Rivaroxaban in people with Peripartum Cardiomyopathy, Postpartum, run by Dennis M. McNamara, MD, MS at 64 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Peripartum Cardiomyopathy, Postpartum
What is being tested?
Bromocriptine, Guideline Directed Medical Therapy for Heart Failure (GDMT) and Rivaroxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
64 sitesUnited States
Study dates
27 Jul 2022to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

64 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dennis McNamara, MD contact

412-802-3131

mcnamaradm@upmc.edu

64 sites in 1 country

United States64 sites, 61 recruiting

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18105

    Withdrawn

  • University of Michigan

    Ann Arbor, Michigan, 48109

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

    Melinda Davis, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Eisha Udeshi, 404-712-1961, eudeshi@emory.edu

    Nino Kavtaradze, (404) 712-0502, nkavtar@emory.edu

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Jamie Demmitt, BA, 720-808-1989, jamie.demmitt@cuanschutz.edu

    Michael Rosenberg, MD

    Recruiting

  • University of Maryland Medical Center, Baltimore

    Baltimore, Maryland, 21201

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

    Lisa Forbess, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Yavette Goldsborough, 410-614-4449, ygoldsb1@jhmi.edu

    Nisha Gilotra, M.D.

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35205

    LaTangellia Walker, (205) 934-4225, latangelliadwalker@uabmc.edu

    Nancy Saxon, (205) 934-1616, nbsaxon@uabmc.edu

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Monica Duan, (781) 690-4657, mduan2@mgb.org

    Nandita S. Scott, MD FACC

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

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

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

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Meghan Sesera, RN, 802-847-4746, meghan.sesera@uvmhealth.org

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

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Virginia Theodorof, (843) 876-9078, theodoro@musc.edu

    Olivia Washington, (843) 876-5785, washoliv@musc.edu

    Recruiting

  • Atrium Health Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204

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

    Catarina Canha, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Frankie Shelton, (434) 982-1058, ZSB5KR@uvahealth.org

    Caroline Flournoy, 4349246104, clf4w@uvahealth.org

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

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

    Priya Freaney, MD

    Recruiting

  • University of Illinois Health Heart Center

    Chicago, Illinois, 60612

    Muriel Chen, 312-355-1861, yining@uic.edu

    Joan Briller, MD

    Recruiting

  • University Hospitals, Cleveland Medical Center

    Cleveland, Ohio, 44106

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

    Chantal ElAmm, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Barbara Gus, (216) 445-6552, gusb@ccf.org

    Karlee Hoffman, MD

    Recruiting

  • Karen L Florio, MD

    Columbia, Missouri, 65201

    Kaycee Mackanos, (573) 817-3386, kmznn@umsystem.edu

    Karen L Florio, MD

    Recruiting

  • UT Southern Medical Center

    Dallas, Texas, 75390-8830

    Withdrawn

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Jodi Carter, 313-916-3613, jcarte23@hfhs.org

    Ryhm Radjef, M.D.

    Recruiting

  • Inova Healthcare Services

    Fairfax, Virginia, 22031

    Joanne Wotring, 571-472-2919, joanne.wotring@inova.org

    Garima Sharma, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32608

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

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

    Recruiting

  • Stern Cardiovascular Foundation, Inc

    Germantown, Tennessee, 38138

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

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

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06106

    Khadija El Aoudi, 860-972-3167, Khadija.ElAoudi@hhchealth.org

    Jennifer Bell, MD

    Recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Katie Loffredo, 717-531-6855, kloffredo@pennstatehealth.psu.edu

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

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

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

    Christopher Broda

    Recruiting

  • Indiana University/Indiana University Health

    Indianapolis, Indiana, 46202

    Srdjan Kurbalija, 317 962 9904, skurbalija@iuhealth.org

    Roopa Rao, MD

    Recruiting

  • Ascension St. Vincent Heart Center

    Indianapolis, Indiana, 46260

    Anne Renick, 317-338-6152, anne.renick@ascension.org

    Regina Margiotti, 317-338-6151, RAMARGIO@ascension.org

    Recruiting

  • University of Iowa Hospitals and Clinic

    Iowa City, Iowa, 52242

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

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

    Recruiting

  • Mayo Clinic, Florida

    Jacksonville, Florida, 32216

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

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

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64154

    Rosann Gans, RN, (816) 932-6122, rgans@saint-lukes.org

    Anna Grodzinsky, MD,MSc

    Recruiting

  • University of California San Diego

    La Jolla, California, 92037-7411

    Rachel Han, rah015@health.ucsd.edu

    Hilary Shapiro, MD

    Recruiting

  • University of Kentucky, Gill Heart & Vascular Institute

    Lexington, Kentucky, 40536

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

    Travis Sexton, (859) 323-1082, trsext2@uky.edu

    Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

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

    Uri Elkayam, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Odette Chida Ibarra, 310-423-9459, odette.chidaibarra@cshs.org

    Janet Wei, MD

    Recruiting

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

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

    Allexa Licon, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Faith Boemer, (414) 955-6854, fboerner@mcw.edu

    Scott Cohen, MD

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

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

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

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Melanie Farinella, (612) 626-4611, crawl027@umn.edu

    Bhavadharini Ramu, MD

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

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

    Rami Alharethi, M.D.

    Recruiting

  • Vanderbilt

    Nashville, Tennessee, 37232

    Olivia Patridge, olivia.h.patridge@vumc.org

    Julie Damp, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Cinthia S De Freitas, (203) 785-6315, cinthia.defreitas@yale.edu

    Sara Tabtabai, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10022

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

    Christina Penfield, MD

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Lovelyne Julien, 845-659-1926, lovelyn.julien@mountsinai.org

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

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

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

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

    Recruiting

  • Old Dominion University

    Norfolk, Virginia, 23507

    Kristin Ayers, 757-446-0529, ayerskl@evms.edu

    Gloria Too, MD

    Recruiting

  • Oklahoma university Health Science Center

    Oklahoma City, Oklahoma, 73104

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

    Tarun Dasari, M.D.

    Recruiting

  • University of California Irvine Health

    Orange, California, 92868

    Linh Huỳnh, MPH, (714) 456-6155, plhuynh@hs.uci.edu

    Afshan Hameed, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

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

    Hossain

    Recruiting

  • Temple Heart and Vascular Institute

    Philadelphia, Pennsylvania, 19140

    Jennie Wong, 215 707-0061, jennie.wong@tuhs.temple.edu

    Deborah Crabbe, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15237

    Dennis McNamara, MD, 412-802-3131, mcnamaradm@upmc.edu

    Donna Simpson, CRNP, MPH, 412-692-3522, simpsondm@upmc.edu

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Kelly Franchetti, RN, 401-444-9828, kfranchetti@lifespan.org

    Athena Poppas, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

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

    Saima Shikari-Dossaji, MD

    Recruiting

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

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

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

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Lori Caufield, RN BSN CCRC, 585-273-4956, lori_caufield@urmc.rochester.edu

    Jeffrey Alexis, MD

    Recruiting

  • University of Texas Health San Antonio

    San Antonio, Texas, 78229

    Withdrawn

  • University of Washington Medical Center

    Seattle, Washington, 98195

    Adele Stefanowicz, 206-616-6768, amstef99@cardiology.washington.edu

    April Stempien-Otero, MD, FACC

    Recruiting

  • Louisiana State University

    Shreveport, Louisiana, 71103

    Monicah Jepkemboi, 318-675-8882, monicah.jepkemboi@lsuhs.edu

    Kalgi Modi, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Annie Dirks, (314) 454-8711, aplatts@wustl.edu

    Lesley Alexander, (314) 273-1425, alesley@wustl.edu

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Tamara Bazouzi, (650) 723-7024, bazouzit@stanford.edu

    Abha Khandelwal, M.D.

    Recruiting

  • Stony Brook Medicine

    Stony Brook, New York, 11794

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

    Hal Skopicki, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Amanda McNamara, (813) 396-2729, alett1@usf.edu

    Laura Cordero, (813) 716-0758, lauracordero@usf.edu

    Recruiting

  • Albert Einstein College of Medicine/ Montefiore Medical Center

    The Bronx, New York, 10461

    Vanya Prasad, (718) 920-2010, vprasad@montefiore.org

    Sandhya Murthy, M.D.

    Recruiting

  • University of Arizona Sarver Heart Center

    Tucson, Arizona, 85724

    Lizzette Cruz, 520-626-2471, marquez@shc.arizona.edu

    Elizabeth Juneman, MD

    Recruiting

Other trials in United States

About this study

Official title: Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH)

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.

Read the detailed description

The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery. All women will have an assessment of LVEF demonstrating an LVEF < or = 0.40 within 4 weeks prior to consent. The women in the breastfeeding cohort will have a qualifying LVEF < 0.40 within 8 weeks prior to consent. At entry they will then have an assessment of LVEF by echocardiogram which will be repeated at 6- and 12-months post study entry. Subjects in the randomized trial will be randomized to standard medical therapy for heart failure plus placebo or standard therapy plus 8 weeks of bromocriptine (2.5 mg twice daily for 2 weeks then once 2.5 mg daily for 6 weeks). Women receiving bromocriptine not currently on anticoagulation will also receive prophylactic anticoagulation with rivaroxaban 10 mg once daily for 8 weeks.

Primary analysis will compare LVEF at 6 months post entry in the women receiving standard therapy plus bromocriptine to those on standard therapy plus placebo (controlling for initial baseline LVEF). Secondary endpoints will analyze the LVEF in both treatment groups at 12 months post randomization. In addition, subjects will be followed for up to 3 years post randomization and survival free from a major event (cardiac transplantation or durable LVAD implantation) and survival free from heart failure hospitalization will be compared by treatment group.

The benefits of bromocriptine are theoretically related to suppression of prolactin secretion. Breastfeeding increases prolactin levels, and whether continued breastfeeding will impact myocardial recovery in women with peripartum cardiomyopathy remains unknown. As bromocriptine prevents breastfeeding, women who want to continue breastfeeding are excluded from the randomized trial. 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 standard therapy with no additional intervention 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.

Blood will be obtained at entry for DNA banking, and analysis of serum, and whole blood RNA . Additional serum and whole blood RNA will be banked at 1-, 3-, and 6-months post randomization. This investigation will evaluate the impact of bromocriptine therapy on the levels of intact 23 kilodalton (kDa) prolactin and the 16 kDa prolactin fragment, as well as microRNA (miR) 146a. The biomarker analysis will also be performed in the observational cohort of women excluded due to continued breast feeding. The impact of these biomarkers on outcomes in both the treatment and control groups as well as the observational cohort excluded due to breastfeeding will be examined.

A core laboratory will analyze all echocardiograms. In addition to quantifying the LVEF at entry, 6 months and 12 months post entry, the core will evaluate global longitudinal strain (LGS) and remodeling (LV volumes) at entry as predictors of outcome and drug response. They will also evaluate the impact of therapy on LGS and LV volumes at 6- and 12-months post randomization.

Being tested
Bromocriptine, Placebo, Guideline Directed Medical Therapy for Heart Failure (GDMT), Rivaroxaban, Second Placebo
Medical subject headings
Peripartum Cardiomyopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BromocriptineDrug

    Also called Parlodel, Cycloset

    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.

  • PlaceboDrug

    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)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),

  • RivaroxabanDrug

    Also called Xarelto

    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 PlaceboDrug

    Also called 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.

Study groups in NCT05180773
Study groupRoleWhat they receive
Bromocriptine Treatment ArmActive comparator100 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.
Receives: Drug: Bromocriptine; Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT); Drug: Rivaroxaban
Placebo ArmPlacebo comparator100 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.
Receives: Drug: Placebo; Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT); Drug: Second Placebo
Breastfeeding Observational CohortOtherUp 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.
Receives: Drug: Guideline Directed Medical Therapy for Heart Failure (GDMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (3)

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

    Measured: 12 months

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

    Measured: 3 years

  3. Survival free from heart failure hospitalization

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start27 Jul 2022
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180773
Sponsor's protocol ID
STUDY21090058
Other IDs
UG3HL153847
Acronym
REBIRTH
Status last verified
Jul 2026
First submitted
9 Dec 2021
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wang T, Ibarra AJ, Simpson D, Kirsch J, Koczo A, Briller JE, Abebe KZ, McNamara D, Givertz MM. Bromocriptine for Myocardial Recovery in Peripartum Cardiomyopathy: Design and Rationale of the REBIRTH Trial. JACC Heart Fail. 2026 Oct 21:103376. doi: 10.1016/j.jchf.2026.103376. Online ahead of print.

    PubMed 42911149

  • 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.

    PubMed 36745273

  • 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.

    PubMed 36202537

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bromocriptine, Guideline Directed Medical Therapy for Heart Failure (GDMT) and Rivaroxaban in people with Peripartum Cardiomyopathy, Postpartum, run by Dennis M. McNamara, MD, MS at 64 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dennis McNamara, MD (412-802-3131, mcnamaradm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180773, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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