Peripartum Cardiomyopathy
Conditions
Keywords
PPCM, Bromocriptine, Peripartum cardiomyopathy
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.
Interventions
DRUGBromocriptine
OTHERGuideline-driven medical therapy (GDMT)
Sponsors
Canadian Cardiovascular Society
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. 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; 3. Recent onset of PPCM ( 1 month); 4. Written informed consent.
Exclusion criteria
1. Hypersensitivity or contraindication to bromocriptine; 2. Patients already taking bromocriptine for PPCM or for another indication; 3. Cardiogenic shock before enrolment; 4. Survival expected to be less than 1 year due to non-cardiovascular causes (eg. cancer); 5. Participation to another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed); 6. Patients who in the opinion of the investigator will not comply with specified drugs, or follow-up evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 1 year | MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of all-cause hospitalisation | 5 years | — |
| Death from cardiovascular causes | 5 years | — |
| Left ventricular ejection fraction (LVEF) recovery | 6 months | Recovery defined as : (proportion of patients with LVEF ≥ 54%) |
| All-cause mortality | 5 years | — |
| Occurence of arrythmias | 1 year | Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation |
| Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF) | 1 year | — |
| Heart transplantation | 5 years | — |
| Mechanical circulatory support | 1 year | — |
| Number of hospitalisation for cardiovascular causes | 5 years | — |
| Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ) | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety adverse events | 12 months | Safety adverse events: Combined occurence of venous thromboembolic disease, cardiac thrombus with embolic manifestation, myocardial infarction or cerebrovascular accident. |
Countries
Canada
Outcome results
None listed