Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripartum Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bromocriptine

Intervention Type DRUG

Guideline-driven medical therapy (GDMT)

Intervention Type OTHER

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

Group Type OTHER

Guideline-driven medical therapy (GDMT)

Intervention Type OTHER

Interventions

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Bromocriptine

Intervention Type DRUG

Guideline-driven medical therapy (GDMT)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No