World Health Organization cardiovascular disease risk charts: revised models to estimate risk in 21 global regions.
WHO CVD Risk Chart Working Group
https://pubmed.ncbi.nlm.nih.gov/31488387Actively Recruiting
Phase 3
Age: 18Years - 50Years
FEMALE
ID06250257
Effect of Bromocriptine in Dilated Cardiomyopathy in Women of Reproductive Age: A Hospital-Based Randomized Open Label Placebo-controlled Clinical Trial
Led by Jimma University · Updated on 2024-11-19
112
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
Jimma University
Lead Sponsor
L
Ludwig-Maximilians - University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Dilated cardiomyopathy (DCM) is a heart condition that causes enlargement and weakening of the heart's ventricles, leading to heart failure, especially in younger adults. This research evaluates the potential benefits of the drug bromocriptine in women of reproductive age with DCM. Bromocriptine has shown promise in treating a related condition called peripartum cardiomyopathy (PPCM) by reducing harmful hormone levels, and this study aims to see if it can help a broader group of women with DCM. The trial compares two groups of women with DCM: one group receives bromocriptine 2.5 mg orally every day for 8 weeks along with standard heart failure treatment, and the other group receives placebo pills plus standard treatment. The study is randomized and open-label, meaning participants are assigned by chance to either group, and both groups receive guideline-directed medical therapy. Bromocriptine's effects on heart function and safety will be closely monitored during the treatment period. Participants will be followed for up to 12 months, with assessments at 3, 6, 9, and 12 months. These include tests of heart function, blood markers related to heart failure, clinical evaluations, and quality of life measures. Researchers will also track hospitalizations and functional improvements. The study will measure bromocriptine blood levels to understand how the drug behaves in this population, aiming to provide detailed information about its potential benefits and safety.
CONDITIONS
Brief Title
Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 50 years
- Diagnosed with ischemic or new onset dilated cardiomyopathy
You will not qualify if you...
- Severe other illnesses that may worsen the condition
- Hypertensive heart disease
- Rheumatic valvular heart disease
- Restrictive, constrictive, or hypertrophic cardiomyopathy
- Congenital heart diseases
- Acute coronary syndrome
- Kidney failure with serum creatinine level 1.4 mg/dl or higher
- History of peripartal cardiomyopathy, pregnancy, planned pregnancy during the study, or breastfeeding
- Previous adverse reaction to bromocriptine
- Unwillingness to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either bromocriptine 2.5 mg daily for 8 weeks plus standard heart failure therapy or placebo plus standard therapy.
Weekly visits for up to 8 weeks
Follow-up
Duration - Up to 12 months
Participants are monitored for cardiac function, clinical improvement, hospitalization, and quality of life after treatment ends.
Visits at 3, 6, 9, and 12 months
Trial Site Locations
Total: 1 location
1
Jimma Medical Center
Jimma, Oromiya, Ethiopia, 378
Actively Recruiting
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Research Team
K
Kedir N Tukeni, MD
E
Esayas K Gudina, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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