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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Montreal Heart Institute
Monteal, Quebec, Canada
MACE
MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.
Time frame: 1 year
Death from cardiovascular causes
Time frame: 5 years
Left ventricular ejection fraction (LVEF) recovery
Recovery defined as : (proportion of patients with LVEF ≥ 54%)
Time frame: 6 months
All-cause mortality
Time frame: 5 years
Occurence of arrythmias
Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation
Time frame: 1 year
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
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Number of hospitalisation for cardiovascular causes
Time frame: 5 years