Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Peripartum Cardiomyopathy Clinical Trial

— BRO-HF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02590601
• Other study ID #: MP-33-2015-1874 (MP)
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 1, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Peripartum Cardiomyopathy

Intervention

Drug:
• Bromocriptine

Other:
• Guideline-driven medical therapy (GDMT)

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Monteal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Canadian Cardiovascular Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety adverse events	Safety adverse events: Combined occurence of venous thromboembolic disease, cardiac thrombus with embolic manifestation, myocardial infarction or cerebrovascular accident.	12 months
Primary	MACE	MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.	1 year
Secondary	Death from cardiovascular causes		5 years
Secondary	Left ventricular ejection fraction (LVEF) recovery	Recovery defined as : (proportion of patients with LVEF = 54%)	6 months
Secondary	All-cause mortality		5 years
Secondary	Occurence of arrythmias	Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation	1 year
Secondary	Number of all-cause hospitalisation		5 years
Secondary	Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ)		1 year
Secondary	Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF)		1 year
Secondary	Heart transplantation		5 years
Secondary	Mechanical circulatory support		1 year
Secondary	Number of hospitalisation for cardiovascular causes		5 years