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Recruiting Phase 3 NCT06250257

Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Trial Parameters

Condition Dilated Cardiomyopathy
Sponsor Jimma University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 112
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2024-10-21
Completion 2026-05-30
Interventions
Bromocriptine mesylate plus standard GDMT

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

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