Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorJimma University

About this trial

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

Qualifiers

Women age 18 years to 50 years and

ischemic or de novo dilated cardiomyopathy

Disqualifiers

Patients with severe comorbidities which may worsen their illness

with hypertensive heart diseases

Rheumatic valvular heart diseases

Restrictive cardiomyopathy, constrictive cardiomyopathy, hypertrophic cardiomyopathy

Trial design

Treatments tested in this trial

  • Bromocriptine mesylate plus standard GDMT

Treatment groups

112 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jimma University

Lead sponsor

Ludwig-Maximilians - University of Munich

Collaborator