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Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy

Study acronym: REBIRTH
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jun 30, 2026 → Jun 30, 2028
See other at-risk trials from Dennis M. McNamara, MD, MS

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 30, 2026 to Jun 30, 2028
    • Site contacts updated at 40 of 64 sites
    v14
  2. Site details revised at 16 of 64 sitesv13
  3. Study sites: 63 to 64v12
  4. Study sites: 57 to 63v11
  5. Study sites: 53 to 57v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 39 to 53
    • Eligibility criteria expanded, about 20 words
    • Study description expanded, about 19 words
    v9
  2. Study sites: 30 to 39v8
  3. Study sites: 22 to 30v7 Show 4 more changesShow less
    • Primary completion date: Aug 30, 2026 to Jun 30, 2026
    • Study completion date: Jan 30, 2027 to Dec 31, 2028
    • Eligibility criteria revised
    • Study description revised
  4. Study sites: 1 to 22v6
  5. Start date changed from estimate of Jul 1, 2022 to Jul 27, 2022v5
  6. Lead sponsor: Dennis McNamara to Dennis M. McNamara, MD, MS
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 15, 2022 to Jul 1, 2022
    • Site details revised
    v4
  7. Start date: Feb 15, 2022 to Mar 15, 2022v3
  8. Start date: Jan 1, 2022 to Feb 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05180773
Lead Sponsor Dennis M. McNamara, MD, MS
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Peripartum Cardiomyopathy, Postpartum
Related terms Peripartum Cardiomyopathy
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov