Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorJimma University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Bromocriptine mesylate plus standard GDMT

    Drug

    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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Left ventricular function improvement

Left ventricular function change measured in terms of ejection fraction and fractional shortening.

Time frame
at 3, 6 and 9 months
2

Improvement of cardiac biomarkers (N-terminal Pro BNP)

Change in cardiac biomarkers measured as N-terminal Pro BNP.

Time frame
Measured at 3, 6 and 9 months
3

Clinical improvement assessment tests

Exercise capacity improvement test with 6-minute walk test and stair climbing tests

Time frame
At recruitment, at 3,6, 9 and 12 months

Secondary outcomes

1

Change in hospitalization pattern

Change in hospitalization as compared with measurements before and after intervention

Time frame
At 9 months and 1 year
2

Functional class of heart failure Improvement

Change in NYHAF class as measured clinically and compared to the baseline status.

Time frame
At 9 months and one year
3

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.

Time frame
At 9 months and one year

Other outcomes

Sponsors and contacts

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Jimma University

Lead sponsor

Ludwig-Maximilians - University of Munich

Collaborator