Actively Recruiting

Phase 3
Age: 18Years - 50Years
FEMALE
NCT06250257

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

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women age 18 years to 50 years
  • Ischemic or de novo dilated cardiomyopathy
Not Eligible

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

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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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