Clinical Trial: Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Montreal Heart Institute

Current Primary Outcome: MACE [ Time Frame: 1 year ]

MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Death from cardiovascular causes [ Time Frame: 5 years ]
  • Left ventricular ejection fraction (LVEF) recovery [ Time Frame: 6 months ]
    Recovery defined as : (proportion of patients with LVEF ≥ 54%)
  • All-cause mortality [ Time Frame: 5 years ]
  • Occurence of arrythmias [ Time Frame: 1 year ]
    Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation
  • Number of all-cause hospitalisation [ Time Frame: 5 years ]
  • Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ) [ Time Frame: 1 year ]
  • Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF) [ Time Frame: 1 year ]
  • Heart transplantation [ Time Frame: 5 years ]
  • Mechanical circulatory support [ Time Frame: 1 year ]
  • Number of hospitalisation for cardiovascular causes [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: Montreal Heart Institute

Dates:
Date Received: October 12, 2015
Date Started: January 2016
Date Completion:
Last Updated: October 27, 2015
Last Verified: October 2015