Clinical Trial

Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated November 19, 2024 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-02-01; most recent amendment 2024-11-16.
Trial Details
NCT Number NCT06250257
Lead Sponsor Jimma University
Collaborators: Ludwig-Maximilians - University of Munich
Conditions Dilated Cardiomyopathy
Enrollment 112 participants
Start Date 2024-10-21
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-19