NCT06250257 Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age
| NCT ID | NCT06250257 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jimma University |
| Condition | Dilated Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 112 participants in total. It began in 2024-10-21 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dilated cardiomyopathy (DCM) is a condition associated with left and /or right ventricular (LV) dilatation and systolic dysfunction without coronary artery disease or abnormal loading circumstances proportionate to the severity of LV impairment. It is one of the leading causes of heart failure in younger adults. About 35% of patients have genetic mutations affecting cytoskeletal, sarcomere, and nuclear envelope proteins while others are idiopathic and possibly complications of myocarditis. Recently, in patients with peripartum cardiomyopathy (PPCM)-a subtype of dilated cardiomyopathy, high levels of prolactin and its degradation by-products including a cleaved 16kDa N-terminal fragment have emerged as key factors in the pathophysiology. The 16kDa prolactin induces profound endothelial damage and subsequent cardiomyocyte dysfunction and hence heart failure. Bromocriptine has been studied as a potential treatment option and placebo-controlled studies have demonstrated its beneficial role in women with Peripartal cardiomyopathy (PPCM). However, prolactin level may also increase during menstrual cycles of reproductive-age women, which candidates the use of bromocriptine in women of all reproductive ages. The aim of this study is therefore to assess the potential effect of bromocriptine in dilated cardiomyopathy among women of reproductive age.
Eligibility 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
Contact & Investigator
Kedir N Tukeni, MD
PRINCIPAL INVESTIGATOR
Jimma University
Frequently Asked Questions
Who can join the NCT06250257 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Dilated Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06250257 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 112 participants.
Is NCT06250257 currently recruiting?
Yes, NCT06250257 is actively recruiting participants. Contact the research team at Kedir.negesso@ju.edu.et for enrollment information.
Where is the NCT06250257 trial being conducted?
This trial is being conducted at Jimma, Ethiopia.
Who is sponsoring the NCT06250257 clinical trial?
NCT06250257 is sponsored by Jimma University. The principal investigator is Kedir N Tukeni, MD at Jimma University. The trial plans to enroll 112 participants.