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Bromocriptine in the Treatment of Peripartum Cardiomyopathy

NCT02590601 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-04-04

No results posted yet for this study

Summary

Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young women in the puerperal period. Thus far, no specific treatment has been approved to treat this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of survivors have persistent chronic heart failure leading to disabling symptoms and decreased quality of life.

Animal studies have suggested that prolactin is central to the development of PPCM. Prolactin has pro-inflammatory and anti-angiogenic effects that may promote PPCM. Bromocriptine, a central dopamine agonist known to decrease prolactin levels, might thwart its deleterious effects in women suffering from PPCM. Following this rationale, bromocriptine should improve myocardial function in women suffering from PPCM and thus, improve cardiovascular outcomes and healthcare outcomes.

Conditions

  • Peripartum Cardiomyopathy

Interventions

DRUG

Bromocriptine

OTHER

Guideline-driven medical therapy (GDMT)

Sponsors & Collaborators

  • Canadian Cardiovascular Society

    collaborator OTHER

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Robert Avram, MD · Université de Montréal

  • Maxime Tremblay-Gravel, MD, MSc · Université de Montréal

  • Guillaume Marquis-Gravel, MD, MSc · Université de Montréal

  • Olivier Desplantie, MD CM, FRCPC · Université de Montréal

  • Anique Ducharme, MD FRCPC · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • Canada

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590601 on ClinicalTrials.gov