Peripartum CardiomyopathyPhase 3BRO-HFNCT02590601
Bromocriptine in the Treatment of Peripartum Cardiomyopathy
A Phase 3 study testing Bromocriptine and Guideline-driven medical therapy (GDMT) in people with Peripartum Cardiomyopathy, run by Montreal Heart Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripartum Cardiomyopathy
- What is being tested?
- Bromocriptine and Guideline-driven medical therapy (GDMT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 1 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial
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.
- Conditions
- Peripartum Cardiomyopathy
- Being tested
- Bromocriptine, Guideline-driven medical therapy (GDMT)
- Keywords
- PPCM, Bromocriptine, Peripartum cardiomyopathy
- Medical subject headings
- Peripartum Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromocriptineDrug
Guideline-driven medical therapy (GDMT)Other
| Study group | Role | What they receive |
|---|---|---|
| Bromocriptine + Guideline-driven medical therapy | Active comparator | 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. Receives: Drug: Bromocriptine; Other: Guideline-driven medical therapy (GDMT) |
| Guideline-driven medical therapy | Other | 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 Receives: Other: Guideline-driven medical therapy (GDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.
Measured: 1 year
Secondary outcomes (10)
Death from cardiovascular causes
Measured: 5 years
Left ventricular ejection fraction (LVEF) recovery
Recovery defined as : (proportion of patients with LVEF ≥ 54%)
Measured: 6 months
All-cause mortality
Measured: 5 years
Occurence of arrythmias
Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation
Measured: 1 year
Number of all-cause hospitalisation
Measured: 5 years
Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ)
Measured: 1 year
Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF)
Measured: 1 year
Heart transplantation
Measured: 5 years
Mechanical circulatory support
Measured: 1 year
Number of hospitalisation for cardiovascular causes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Why it stopped: Not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripartum CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cardiovascular Society
- Responsible party
- Principal investigator, Marc Jolicoeur, Montreal Heart Institute
- Investigators
- Robert Avram, MD, Principal investigator, Université de MontréalMaxime Tremblay-Gravel, MD, MSc, Principal investigator, Université de MontréalGuillaume Marquis-Gravel, MD, MSc, Principal investigator, Université de MontréalOlivier Desplantie, MD CM, FRCPC, Principal investigator, Université de MontréalAnique Ducharme, MD FRCPC, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590601
- Sponsor's protocol ID
- MP-33-2015-1874 (MP)
- Acronym
- BRO-HF
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2015
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30051292
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial
- ClinicalTrials.gov ID
- NCT02590601
- Acronym / sponsor ID
- BRO-HF / MP-33-2015-1874 (MP)
- Conditions
- Peripartum Cardiomyopathy
- Keywords
- PPCM, Bromocriptine, Peripartum cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Canadian Cardiovascular Society
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bromocriptine + Guideline-driven medical therapy | Active comparator | Drug: Bromocriptine, Other: Guideline-driven medical therapy (GDMT)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. |
| Guideline-driven medical therapy | Other | Other: Guideline-driven medical therapy (GDMT)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- Peripartum cardiomyopathy defined by the following criteria:
- Recent onset of PPCM ( 1 month);
- Written informed consent.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromocriptine | Drug | Bromocriptine + Guideline-driven medical therapy |
| Guideline-driven medical therapy (GDMT) | Other | Bromocriptine + Guideline-driven medical therapy, Guideline-driven medical therapy |
Primary outcome
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.
10 secondary outcomes
Death from cardiovascular causes
Time frame: 5 years
Left ventricular ejection fraction (LVEF) recovery
Time frame: 6 months
All-cause mortality
Time frame: 5 years
Occurence of arrythmias
Time frame: 1 year
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 30051292Azibani F, Sliwa K. Peripartum Cardiomyopathy: an Update. Curr Heart Fail Rep. 2018 Oct;15(5):297-306. doi: 10.1007/s11897-018-0404-x.
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Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Avram, MD principal investigator
Université de Montréal
Maxime Tremblay-Gravel, MD, MSc principal investigator
Université de Montréal
Guillaume Marquis-Gravel, MD, MSc principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bromocriptine and Guideline-driven medical therapy (GDMT) in people with Peripartum Cardiomyopathy, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.