Bromocriptine in the Treatment of Peripartum Cardiomyopathy (BRO-HF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02590601|
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : September 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripartum Cardiomyopathy||Drug: Bromocriptine Other: Guideline-driven medical therapy (GDMT)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Active Comparator: Bromocriptine + Guideline-driven medical therapy
In 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.
Other: Guideline-driven medical therapy (GDMT)
Guideline-driven medical therapy
New 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
Other: Guideline-driven medical therapy (GDMT)
- MACE [ Time Frame: 1 year ]MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.
- Death from cardiovascular causes [ Time Frame: 5 years ]
- Left ventricular ejection fraction (LVEF) recovery [ Time Frame: 6 months ]Recovery defined as : (proportion of patients with LVEF ≥ 54%)
- All-cause mortality [ Time Frame: 5 years ]
- Occurence of arrythmias [ Time Frame: 1 year ]Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation
- 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 ]
- Number of hospitalisation for cardiovascular causes [ Time Frame: 5 years ]
- Safety adverse events [ Time Frame: 12 months ]Safety adverse events: Combined occurence of venous thromboembolic disease, cardiac thrombus with embolic manifestation, myocardial infarction or cerebrovascular accident.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590601
|Contact: Marc Jolicoeur, MD, M.Sc., MHS||514-376-3330 ext email@example.com|
|Contact: Marie-Gabrielle Lessard, RN, B.Sc.||Phone: 514-376-3330 ext firstname.lastname@example.org|
|Montreal Heart Institute||Recruiting|
|Monteal, Quebec, Canada, H1T 1C8|
|Contact: Marc Jolicoeur, MD, M.Sc., MHS 514-376-3330 ext 3685 email@example.com|
|Contact: Luc Harvey, RN 514-376-3330 ext 2776 firstname.lastname@example.org|
|Principal Investigator: Anique Ducharme, MD, FRCPC|
|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|