Clinical trial NCT02590601: Bromocriptine in the Treatment of Peripartum Cardiomyopathy
Official title: Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Peripartum Cardiomyopathy
Keywords: PPCM
Bromocriptine
Peripartum cardiomyopathy
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Canadian Cardiovascular Society
First posted: 2015-10-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: Death from cardiovascular causes
timeFrame: 5 years
measure: Left ventricular ejection fraction (LVEF) recovery
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 5 years
measure: Occurence of arrythmias
timeFrame: 1 year
measure: Number of all-cause hospitalisation
timeFrame: 5 years
measure: Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ)
timeFrame: 1 year
measure: Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF)
timeFrame: 1 year
measure: Heart transplantation
timeFrame: 5 years
measure: Mechanical circulatory support
timeFrame: 1 year
measure: Number of hospitalisation for cardiovascular causes
timeFrame: 5 years
Other outcomes:
measure: Safety adverse events
timeFrame: 12 months
Locations:
city: Monteal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Robert Avram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Maxime Tremblay-Gravel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Guillaume Marquis-Gravel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Olivier Desplantie, MD CM, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute
name: Anique Ducharme, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azibani F, Sliwa K. Peripartum Cardiomyopathy: an Update. Curr Heart Fail Rep. 2018 Oct;15(5):297-306. doi: 10.1007/s11897-018-0404-x.