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Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

NCT06250257 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Dilated Cardiomyopathy

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.

Sponsors & Collaborators

  • Ludwig Maximilian university of Munich

    collaborator UNKNOWN

  • Jimma University

    lead OTHER

Principal Investigators

  • Kedir N Tukeni, MD · Jimma University

  • Haas A Nikolaus, MD, Cardiologist · Ludwig Maximillian university of Munich

  • Estner F Heidi, MD, cardiologist · Ludwig Maximillian university of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-05-30
Completion
2026-11-30

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250257 on ClinicalTrials.gov