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Dopamine Agonist
Bromocriptine for Peripartum Cardiomyopathy (REBIRTH Trial)
Phase 4
Recruiting
Research Sponsored by Dennis McNamara
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
REBIRTH Trial Summary
This trial will test whether the drug bromocriptine can help improve heart function in women who have peripartum cardiomyopathy.
Who is the study for?
This trial is for women over 18 who've been diagnosed with peripartum cardiomyopathy within 5 months after giving birth. They must have a left ventricular ejection fraction (LVEF) of 0.35 or less and cannot be breastfeeding if they wish to participate.Check my eligibility
What is being tested?
The study tests the effect of Bromocriptine, compared to a placebo, on heart muscle recovery in women with recent onset peripartum cardiomyopathy. It also includes standard heart failure therapy and Rivaroxaban, an anticoagulant, versus another placebo.See study design
What are the potential side effects?
Bromocriptine may cause headaches, dizziness, nausea, low blood pressure upon standing up. There's also a risk it could inhibit lactation in new mothers.
REBIRTH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
REBIRTH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Left ventricular ejection fraction (LVEF) at 6 months post entry as determined by echocardiography
Secondary outcome measures
Left ventricular ejection fraction (LVEF) at 12 months post entry as determined by echocardiography
Survival free from cardiac transplantation or implantation of a durable left ventricular assist device (LVAD)
Survival free from heart failure hospitalization
Other outcome measures
Global longitudinal strain (GLS) at 12 months post entry as determined by echocardiography
Global longitudinal strain (GLS) at 6 months post entry as determined by echocardiography
Left ventricular volumes at 12 months post entry as determined by echocardiography
+1 moreREBIRTH Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Breastfeeding Observational CohortExperimental Treatment1 Intervention
Up to 50 women meeting all other criteria but excluded from REBIRTH due to an intent to continue to breastfeed will be enrolled in an observational cohort. They will receive guideline directed medical therapy with no additional interventions and will have the same follow up and assessment of myocardial recovery by echocardiogram at 6 and 12 months post entry as women in the randomized trial.
Group II: Bromocriptine Treatment ArmActive Control3 Interventions
100 Women in the Treatment Arm will receive guideline directed medical therapy for heart failure plus 8 weeks of bromocriptine administered orally as 2.5 mg twice daily for 2 weeks then 2.5mg once daily for 6 weeks. Women not on clinical anticoagulation will also receive prophylactic anticoagulation with rivaroxaban 10 mg once daily for 8 weeks while on bromocriptine.
Group III: Placebo ArmPlacebo Group3 Interventions
100 Women in the Placebo Arm will receive guideline directed medical therapy for heart failure plus 8 weeks of a placebo administered orally twice daily for 2 weeks then once daily for 6 weeks. Women not on clinical anticoagulation will not receive rivaroxaban but will instead receive a second placebo for 8 weeks.
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Who is running the clinical trial?
Dennis McNamaraLead Sponsor
Dennis M. McNamara, MD, MSLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,344 Total Patients Enrolled
10 Trials studying Cardiomyopathy
16,952 Patients Enrolled for Cardiomyopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy or chest radiation in the last 5 years.I have had heart disease, except for fully recovered peripartum cardiomyopathy.I am 18 years old or older.My blood pressure is very high and hard to control.I currently have a bacterial blood infection.
Research Study Groups:
This trial has the following groups:- Group 1: Bromocriptine Treatment Arm
- Group 2: Placebo Arm
- Group 3: Breastfeeding Observational Cohort
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants being recruited for this research endeavor?
"According to clinicaltrials.gov, this experimental trial is open for recruitment and was first published on July 27th 2022 with the most recent update occurring September 20th 2022."
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