Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Dilated Cardiomyopathy

In brief

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.

Key facts

Study ID

NCT06250257

Run by

Jimma University

People needed

112

Starts

2024-10-21

Expected to finish

2026-11-30

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women age 18 years to 50 years and
• ischemic or de novo dilated cardiomyopathy

You may not qualify if…

• 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

Where it is running

• Jimma Medical Center — Jimma, Oromiya, Ethiopia (enrolling)

Full record on ClinicalTrials.gov

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