Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial

Trial Information
Who is this study for? Patients with Peripartum Cardiomyopathy
What treatments are being studied? Guideline-Driven Medical Therapy (GDMT)
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Am I eligible for this trial?
Participation Requirements
Sex:
Female
Minimum Age:
18
Healthy Volunteers:
No

• Age ≥ 18 years;

• Peripartum cardiomyopathy defined by the following criteria:

• Development of heart failure in the last month of pregnancy or within 5 months of delivery;

• Absence of an identifiable alternative cause of heart failure;

• Absence of recognizable heart disease prior to the last month of pregnancy;

• Left ventricular systolic dysfunction demonstrated by classic echocardiographic criteria, such as depressed ejection fraction;

• Recent onset of PPCM ( 1 month);

• Written informed consent.

Where is this trial taking place?
Other Locations
Canada
Montreal Heart Institute
Recruiting
Monteal
Who do I contact about this trial?
Primary
Marc Jolicoeur, MD, M.Sc., MHS
marc.jolicoeur@icm-mhi.org
514-376-3330
Backup
Marie-Gabrielle Lessard, RN, B.Sc.
marie-gabrielle.lessard@icm-mhi.org
Phone: 514-376-3330
When is this trial taking place?
Start Date: January 1, 2017
Estimated Completion Date: January 1, 2023
How many participants will be in this trial?
Target number of participants: 80
What treatment is being studied in this trial?
Active Comparator: Bromocriptine + Guideline-driven medical therapy
In addition to heart failure treatment described above, patients will be administered bromocriptine 2.5 mg orally twice daily for 14 days, followed by 2.5 mg orally daily for 42 days.~Although not a study procedure, we recommend anticoagulation with prophylactic doses of subcutaneous low-molecular weight heparin during the whole duration of bromocriptine therapy.
Other: Guideline-driven medical therapy
New onset PPCM will be managed according to the principles of guideline-driven medical therapy for new-onset heart failure as per the position statement for treatment of PPCM published by the European Society of Cardiology (ESC) and the Canadian Cardiovascular Society (CCS) update on heart failure and pregnancy . The choices and administration of GDMT will be left at the discretion of the treating physician
Who are the authors of this trial?
Maxime Tremblay-Gravel, Guillaume Marquis-Gravel, Olivier Desplantie, Anique Ducharme, Robert Avram
What other conditions are being studied in this trial?

This content was sourced from clinicaltrials.gov