About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women age 18 years to 50 years and
ischemic or de novo dilated cardiomyopathy
Disqualifiers
Patients with severe comorbidities which may worsen their illness
with hypertensive heart diseases
Rheumatic valvular heart diseases
Restrictive cardiomyopathy, constrictive cardiomyopathy, hypertrophic cardiomyopathy
Trial design
Parallel
Treatments tested in this trial
Bromocriptine mesylate plus standard GDMT
DrugThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Left ventricular function improvement
Left ventricular function change measured in terms of ejection fraction and fractional shortening.
Improvement of cardiac biomarkers (N-terminal Pro BNP)
Change in cardiac biomarkers measured as N-terminal Pro BNP.
Clinical improvement assessment tests
Exercise capacity improvement test with 6-minute walk test and stair climbing tests
Secondary outcomes
Change in hospitalization pattern
Change in hospitalization as compared with measurements before and after intervention
Functional class of heart failure Improvement
Change in NYHAF class as measured clinically and compared to the baseline status.
Improved quality of life
Change in quality of life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ-12) updated questionnaire, all KCCQ scores will be scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Sponsors and contacts
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Jimma University
Lead sponsor
Ludwig-Maximilians - University of Munich
Collaborator