drugset / Trial / NCT05180773
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Phase 4
Recruiting
250 enrolled
Dennis M. McNamara, MD, MS
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-07-27
- Primary completion
- 2026-06-30
- Completion
- 2028-12-31
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bromocriptine | Small molecule | 2.5 mg | Oral |
| Comparator | Rivaroxaban | Other / unclassified | 10 mg | Oral |