Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (REBIRTH)
Peripartum Cardiomyopathy, Postpartum
About this trial
This is an interventional treatment trial for Peripartum Cardiomyopathy, Postpartum
Eligibility Criteria
Inclusion Criteria:
- Presentation with a new diagnosis of peripartum cardiomyopathy
- Post-delivery and within the first 5 months post-partum.
- Clinical assessment of an LVEF < or =0.35 within 2 weeks of randomization
- Age > or = 18.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama BirminghamRecruiting
- University of Arizona Sarver Heart CenterRecruiting
- Cedars-Sinai Medical CenterRecruiting
- University of California Irvine HealthRecruiting
- Stanford UniversityRecruiting
- University of Colorado Anschutz Medical CampusRecruiting
- University of FloridaRecruiting
- Mayo Clinic, FloridaRecruiting
- Northwestern UniversityRecruiting
- University of Illinois Health Heart CenterRecruiting
- Indiana University/Indiana University HealthRecruiting
- Ascension St. Vincent Heart CenterRecruiting
- University of Kentucky, Gill Heart & Vascular InstituteRecruiting
- Louisiana State UniversityRecruiting
- Johns Hopkins UniversityRecruiting
- Massachusetts General HospitalRecruiting
- Brigham and Women's HospitalRecruiting
- University of MichiganRecruiting
- Henry Ford Health SystemRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Washington University School of MedicineRecruiting
- Albert Einstein College of Medicine/ Montefiore Medical CenterRecruiting
- Columbia University Irving Medical CenterRecruiting
- University of RochesterRecruiting
- University Hospitals, Cleveland Medical CenterRecruiting
- Cleveland ClinicRecruiting
- Oklahoma university Health Science CenterRecruiting
- Lehigh Valley Health NetworkRecruiting
- Penn State Hershey Medical CenterRecruiting
- University of PennsylvaniaRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Rhode Island HospitalRecruiting
- VanderbiltRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- University of Texas Health San AntonioRecruiting
- Intermountain Medical CenterRecruiting
- University of Vermont Medical CenterRecruiting
- University of Washington Medical CenterRecruiting
- Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Other
Bromocriptine Treatment Arm
Placebo Arm
Breastfeeding Observational Cohort
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.
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.
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.