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RECRUITING
NCT06250257
PHASE3

Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Sponsor: Jimma University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-10-21

Completion Date

2026-11-30

Last Updated

2024-11-19

Healthy Volunteers

No

Interventions

DRUG

Bromocriptine mesylate plus standard GDMT

The treatment group will receive bromocriptine 2.5mg PO daily for 8 weeks together with standard GDMT which include similar patterns of BBs, ACEI/ARBs, MRAs and SGLT2 inhibitors.

Locations (1)

Jimma Medical Center

Jimma, Oromiya, Ethiopia