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Bromocriptine in the Treatment of Peripartum Cardiomyopathy (BRO-HF)

Primary Purpose

Peripartum Cardiomyopathy

Status

Withdrawn

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Bromocriptine

Guideline-driven medical therapy (GDMT)

About this trial

This is an interventional treatment trial for Peripartum Cardiomyopathy focused on measuring PPCM, Bromocriptine, Peripartum cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Bromocriptine + Guideline-driven medical therapy

Guideline-driven medical therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

MACE

MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.

Secondary Outcome Measures

Death from cardiovascular causes

Left ventricular ejection fraction (LVEF) recovery

Recovery defined as : (proportion of patients with LVEF ≥ 54%)

All-cause mortality

Occurence of arrythmias

Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation

Number of all-cause hospitalisation

Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ)

Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF)

Heart transplantation

Mechanical circulatory support

Number of hospitalisation for cardiovascular causes

Full Information

NCT ID

NCT02590601

First Posted

October 12, 2015

Last Updated

March 31, 2023

Sponsor

Montreal Heart Institute

Collaborators

Canadian Cardiovascular Society

1. Study Identification

Unique Protocol Identification Number

NCT02590601

Brief Title

Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Acronym

BRO-HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Not enough patients

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montreal Heart Institute

Collaborators

Canadian Cardiovascular Society

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripartum Cardiomyopathy

Keywords

PPCM, Bromocriptine, Peripartum cardiomyopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bromocriptine + Guideline-driven medical therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Guideline-driven medical therapy

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bromocriptine

Intervention Type

Other

Intervention Name(s)

Guideline-driven medical therapy (GDMT)

Primary Outcome Measure Information:

Title

MACE

Description

MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Death from cardiovascular causes

Time Frame

5 years

Title

Left ventricular ejection fraction (LVEF) recovery

Description

Recovery defined as : (proportion of patients with LVEF ≥ 54%)

Time Frame

6 months

Title

All-cause mortality

Time Frame

5 years

Title

Occurence of arrythmias

Description

Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation

Time Frame

1 year

Title

Number of all-cause hospitalisation

Time Frame

5 years

Title

Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ)

Time Frame

1 year

Title

Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF)

Time Frame

1 year

Title

Heart transplantation

Time Frame

5 years

Title

Mechanical circulatory support

Time Frame

1 year

Title

Number of hospitalisation for cardiovascular causes

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Safety adverse events

Description

Safety adverse events: Combined occurence of venous thromboembolic disease, cardiac thrombus with embolic manifestation, myocardial infarction or cerebrovascular accident.

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials: