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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

Must not have

Refractory hypertension (Systolic >160 or Diastolic >95) either at the time of enrollment or at the time of the qualifying LVEF

Evidence of ongoing bacterial septicemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is very high and hard to control.

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I currently have a bacterial blood infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Awards & Highlights

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.

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.

0 / 3Eligibility criteria met