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Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy

NCT00998556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-09-07

No results posted yet for this study

Summary

This is a randomized, controlled clinical trial to evaluate the efficacy and safety of bromocriptine for improvement of left ventricular function of women with Peripartum cardiomyopathy (PPCM). A Multi center trial in Germany.

Conditions

  • Peripartum Cardiomyopathy

Interventions

DRUG

Bromocriptine

Patients randomized to the study medication have to take bromocriptine orally for the first 14 days at a dose of 5 mg/day (= 2 tablets, 1 in morning, 1 in the evening). From day 15 to day 56 they will take a dose of 2.5 mg (= 1 tablet) orally in the evening. The duration of the intervention is 8 weeks. The study medication is taken on top of standard therapy for heart failure.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Johann Bauersachs, Prof. Dr. · Hannover Medical School, Hannover, Germany

  • Denise Hilfiker-Kleiner, Prof. Dr. · Hannover Medical School, Hannover, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-03-31
Completion
2016-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00998556 on ClinicalTrials.gov