Bromocriptine treatment for women with dilated cardiomyopathy
Effect of Bromocriptine in Dilated Cardiomyopathy in Women of Reproductive Age: A Hospital-Based Randomized Open Label Placebo-controlled Clinical Trial
This study is testing if bromocriptine can help improve heart function in women aged 18 to 50 with dilated cardiomyopathy compared to standard treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Jimma University Academic / other |
| Locations | 1 site (Jimma, Oromiya) |
| Trial ID | NCT06250257 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of bromocriptine mesylate in women aged 18 to 50 with dilated cardiomyopathy, a condition characterized by the enlargement and weakening of the heart's ventricles. The study aims to assess the drug's efficacy in improving left ventricular function and overall heart health compared to standard guideline-directed medical therapy. By focusing on the hormonal influences of prolactin in this patient population, the trial seeks to provide insights into a potentially novel treatment approach for a condition that significantly impacts young women. Participants will be monitored for improvements in heart function and any adverse reactions to the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 50 diagnosed with ischemic or de novo dilated cardiomyopathy.
Not a fit: Patients with severe comorbidities, other forms of cardiomyopathy, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for women suffering from dilated cardiomyopathy.
How similar studies have performed: Previous studies have shown promising results with bromocriptine in related conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women age 18 years to 50 years and * ischemic or de novo dilated cardiomyopathy Exclusion Criteria: * Patients with severe comorbidities which may worsen their illness * with hypertensive heart diseases * Rheumatic valvular heart diseases * Restrictive cardiomyopathy, constrictive cardiomyopathy, hypertrophic cardiomyopathy * Congenital heart diseases * Acute coronary syndrome * Overt kidney failure (serum Creatinine ≥ 1.4mg/dl), * Women who had history of peripartal cardiomyopathy, are pregnant or planning pregnancy during the study period or lactating * Previous adverse reaction to the bromocriptine * Patients not willing to participate in the study
Where this trial is running
Jimma, Oromiya
- Jimma Medical Center — Jimma, Oromiya, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Kedir N Tukeni, MD — Jimma University
- Study coordinator: Kedir N Tukeni, MD
- Email: Kedir.negesso@ju.edu.et
- Phone: +251913521475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.