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Dopamine Agonist

Guideline-driven medical therapy for Peripartum Cardiomyopathy (BRO-HF Trial)

Phase 3

Waitlist Available

Led By Robert Avram, MD

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

BRO-HF Trial Summary

This trial will test whether bromocriptine is an effective treatment for peripartum cardiomyopathy.

Eligible Conditions

Peripartum Cardiomyopathy

BRO-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MACE

Secondary outcome measures

All-cause mortality

Death from cardiovascular causes

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

+7 more

Other outcome measures

Safety adverse events

Side effects data

From 2018 Phase 4 trial • 23 Patients • NCT02299050

13%

Orthostatic Hypotension

13%

Light-headedness

13%

Nausea

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Cycloset

BRO-HF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Guideline-driven medical therapyExperimental Treatment1 Intervention

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 II: Bromocriptine + Guideline-driven medical therapyActive Control2 Interventions

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.

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Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

68,819 Total Patients Enrolled

Canadian Cardiovascular SocietyOTHER

6 Previous Clinical Trials

736 Total Patients Enrolled

Robert Avram, MDPrincipal InvestigatorUniversité de Montréal

1 Previous Clinical Trials

55 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other major studies that have looked at the effectiveness of Bromocriptine in combination with current best practices?

"There are 6 ongoing clinical trials studying the efficacy of bromocriptine in combination with guideline-driven medical therapy. One of these trials is currently in Phase 3. There are several locations running these studies, with 8 sites in total spread across Montreal, Quebec and other areas."

Answered by AI

How many people are being asked to participate in this research project?

"The information available on clinicaltrials.gov does show that this study is currently looking for enrollees. The posting date was 1/1/2017 with the most recent update being 9/2/2017. They are aiming to have 80 people participate at 1 location."

Answered by AI

What are the dangers of Bromocriptine + Guideline-driven medical therapy?

"Bromocriptine + Guideline-driven medical therapy is considered safe, as it has reached Phase 3 in clinical trials. This means that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are people still being enrolled in this experiment?

"That is accurate. The clinicaltrial.gov website has the latest information regarding this trial, which originally posted on 1/1/2017 and updated as recently as 9/2/2017. They are looking for 80 participants at a single site."

Answered by AI

What do doctors usually prescribe Bromocriptine + Guideline-driven medical therapy for?

"Bromocriptine + Guideline-driven medical therapy is often used to manage hyperprolactinemia. This treatment method can also be helpful for patients with acromegaly, neuroleptic malignant syndrome (nms), and parkinson's disease (pd)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Marc Jolicoeur 2017. "Bromocriptine in the Treatment of Peripartum Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02590601.