Actively Recruiting
Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age
Led by Jimma University · Updated on 2024-11-19
112
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
J
Jimma University
Lead Sponsor
L
Ludwig-Maximilians - University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women age 18 years to 50 years
- Ischemic or de novo dilated cardiomyopathy
You will not qualify if you...
- Severe comorbidities that may worsen illness
- Hypertensive heart diseases
- Rheumatic valvular heart diseases
- Restrictive, constrictive, or hypertrophic cardiomyopathy
- Congenital heart diseases
- Acute coronary syndrome
- Overt kidney failure with serum creatinine 6 1.4 mg/dl
- History of peripartal cardiomyopathy, pregnancy, planning pregnancy during study, or lactating
- Previous adverse reaction to bromocriptine
- Unwillingness to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jimma Medical Center
Jimma, Oromiya, Ethiopia, 378
Actively Recruiting
Research Team
K
Kedir N Tukeni, MD
CONTACT
E
Esayas K Gudina, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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