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Bromocriptine in the Treatment of Peripartum Cardiomyopathy
BRO-HF
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2017
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedApril 4, 2023
March 1, 2023
6 years
October 12, 2015
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Death from cardiovascular causes
5 years
Left ventricular ejection fraction (LVEF) recovery
6 months
All-cause mortality
5 years
Occurence of arrythmias
1 year
Number of all-cause hospitalisation
5 years
- +5 more secondary outcomes
Other Outcomes (1)
Safety adverse events
12 months
Study Arms (2)
Bromocriptine + Guideline-driven medical therapy
ACTIVE COMPARATORIn addition to heart failure treatment described above, patients will be administered bromocriptine 2.5 mg orally twice daily for 14 days, followed by 2.5 mg orally daily for 42 days. Although not a study procedure, we recommend anticoagulation with prophylactic doses of subcutaneous low-molecular weight heparin during the whole duration of bromocriptine therapy.
Guideline-driven medical therapy
OTHERNew onset PPCM will be managed according to the principles of guideline-driven medical therapy for new-onset heart failure as per the position statement for treatment of PPCM published by the European Society of Cardiology (ESC) and the Canadian Cardiovascular Society (CCS) update on heart failure and pregnancy . The choices and administration of GDMT will be left at the discretion of the treating physician
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years;
- 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;
- Recent onset of PPCM ( 1 month);
- Written informed consent.
You may not qualify if:
- Hypersensitivity or contraindication to bromocriptine;
- Patients already taking bromocriptine for PPCM or for another indication;
- Cardiogenic shock before enrolment;
- Survival expected to be less than 1 year due to non-cardiovascular causes (eg. cancer);
- Participation to another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
- Patients who in the opinion of the investigator will not comply with specified drugs, or follow-up evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montreal Heart Institutelead
- Canadian Cardiovascular Societycollaborator
Study Sites (1)
Montreal Heart Institute
Monteal, Quebec, H1T 1C8, Canada
Related Publications (1)
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.
PMID: 30051292DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Avram, MD
Université de Montréal
- PRINCIPAL INVESTIGATOR
Maxime Tremblay-Gravel, MD, MSc
Université de Montréal
- PRINCIPAL INVESTIGATOR
Guillaume Marquis-Gravel, MD, MSc
Université de Montréal
- PRINCIPAL INVESTIGATOR
Olivier Desplantie, MD CM, FRCPC
Université de Montréal
- PRINCIPAL INVESTIGATOR
Anique Ducharme, MD FRCPC
Montreal Heart Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lead investigator
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 29, 2015
Study Start
January 1, 2017
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
April 4, 2023
Record last verified: 2023-03