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Phase 3
Age: 18Years - 50Years
FEMALE
ID06250257

Study of Bromocriptine Added to Standard Treatment for Dilated Cardiomyopathy in Women Aged 18 to 50

Led by Jimma University · Updated on 2024-11-19

112

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Dilated cardiomyopathy DCM is a heart condition that causes enlargement and weakening of the hearts ventricles, leading to heart failure, especially in younger adults. This research evaluates the potential benefits of the drug bromocriptine in women of reproductive age with DCM. Bromocriptine has shown promise in treating a related condition called peripartum cardiomyopathy PPCM by reducing harmful hormone levels, and this study aims to see if it can help a broader group of women with DCM. The trial compares two groups of women with DCM one group receives bromocriptine 2.5 mg orally every day for 8 weeks along with standard heart failure treatment, and the other group receives placebo pills plus standard treatment. The study is randomized and open-label, meaning participants are assigned by chance to either group, and both groups receive guideline-directed medical therapy. Bromocriptines effects on heart function and safety will be closely monitored during the treatment period. Participants will be followed for up to 12 months, with assessments at 3, 6, 9, and 12 months. These include tests of heart function, blood markers related to heart failure, clinical evaluations, and quality of life measures. Researchers will also track hospitalizations and functional improvements. The study will measure bromocriptine blood levels to understand how the drug behaves in this population, aiming to provide detailed information about its potential benefits and safety.

CONDITIONS

Brief Title

Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Research Team

K

Kedir N Tukeni, MD

E

Esayas K Gudina, MD,PhD

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