Effect of Bromocriptine in Dilated Cardiomyopathy in Women of Reproductive Age: A Hospital-Based Randomized Open Label Placebo-controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Women age 18 years to 50 years and

• ischemic or de novo dilated cardiomyopathy

Locations
Other Locations
Ethiopia
Jimma Medical Center
RECRUITING
Jimma
Contact Information
Primary
Kedir N Tukeni, MD
Kedir.negesso@ju.edu.et
+251913521475
Backup
Esayas K Gudina, MD,PhD
esayas.gudina@ju.edu.et
+251911718500
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 112
Treatments
Active_comparator: Control group
This group of study participants are expected to receive placebo (sucrose pills to be used) plus standard Guideline-directed medical therapy (GDMT).
Experimental: Treatment group
This group of study participants are expected to receive oral daily bromocriptine 2.5 mg for 8 weeks plus standard Guideline-directed medical therapy (GDMT).
Sponsors
Collaborators: Ludwig Maximilian university of Munich
Leads: Jimma University

This content was sourced from clinicaltrials.gov