Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

NCT06250257 | Recruiting Phase 3 DMC

• 1 other identifier: JUIH/IRB/690/23
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dilated cardiomyopathy; left ventricular function; ejection fraction; prolactin; bromocriptine; cardiac biomarkers; quality of life; Exercise capacity; 6-minute walk test; Standard stair climbing test

Outcome Measures

Primary Outcomes (3)

• Left ventricular function improvement

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

  at 3, 6 and 9 months

• Improvement of cardiac biomarkers (N-terminal Pro BNP)

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

  Measured at 3, 6 and 9 months

• Clinical improvement assessment tests

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

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

Secondary Outcomes (3)

• Change in hospitalization pattern

  At 9 months and 1 year

• Functional class of heart failure Improvement

  At 9 months and one year

• Improved quality of life

  At 9 months and one year

Study Arms (2)

Control group

ACTIVE COMPARATOR

This group of study participants are expected to receive placebo (sucrose pills to be used) plus standard Guideline-directed medical therapy (GDMT).

Drug: Bromocriptine mesylate plus standard GDMT

Treatment group

EXPERIMENTAL

This group of study participants are expected to receive oral daily bromocriptine 2.5 mg for 8 weeks plus standard Guideline-directed medical therapy (GDMT).

Drug: Bromocriptine mesylate plus standard GDMT

Interventions

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.

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: All women of reproductive age with diagnosis of dilated cardiomyopathy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Jimma University: lead
• Ludwig Maximilian university of Munich: collaborator

Study Sites (1)

Jimma Medical Center

Jimma, Oromiya, 378, Ethiopia

RECRUITING

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MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kedir N Tukeni, MD

  Jimma University

  PRINCIPAL INVESTIGATOR

• Haas A Nikolaus, MD, Cardiologist

  Ludwig Maximillian university of Munich

  STUDY CHAIR

• Estner F Heidi, MD, cardiologist

  Ludwig Maximillian university of Munich

  STUDY CHAIR

Central Study Contacts

Kedir N Tukeni, MD

CONTACT

+251913521475; Kedir.negesso@ju.edu.et

Esayas K Gudina, MD,PhD

CONTACT

+251911718500; esayas.gudina@ju.edu.et

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: We will share the data after the completion of the study till the study is published online.

Locations

ET (1)