Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age

Dilated Cardiomyopathy Clinical Trial

Official title: Effectiveness of Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age: A Hospital-Based Randomized Open Label Clinical Trial

Status Recruiting

Clinical Trial 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, often requiring cardiac transplantation, and is caused by various factors, including myocarditis, alcohol, drug, and metabolic disturbances. About 35% of patients have genetic mutations affecting cytoskeletal, sarcomere, and nuclear envelope proteins. The prognosis depends on the severity and heart remodeling, with the worst outcomes in patients with low ejection fractions or severe diastolic dysfunction.

Although it is more common in men, DCM also occur in women, and hence hormonal factors can play a role in the development of DCM in women. Bromocriptine has been suggested as a potential treatment option. Bromocriptine is a dopamine agonist that is primarily used to treat conditions such as hyperprolactinemia, and acromegaly. However, it has also been studied in the context of heart failure, and some studies have suggested that it may be beneficial in women with Peripartal cardiomyopathy (PPCM), a form of DCM that occurs in the last month of pregnancy or up to five months postpartum.

The mechanism by which bromocriptine may improve left ventricular function in DCM is not fully understood, but it is thought to be related to its ability to reduce prolactin levels. Prolactin is a hormone that has been shown to be elevated in some cases of DCM, and it may contribute to the development and progression of the condition. To date, the use of bromocriptine is recommended for the treatment of pregnancy-related cardiomyopathy (PPCM) due to a significant increase in prolactin levels. However, prolactin level may increase during menstrual cycles of reproductive-age women, which candidates the use of bromocriptine in women of all reproductive ages. The aims of this study is to assess the use of bromocriptine in terms of LV function improvement, overall improvement of heart failure symptoms and reduced mortality and improved quality of life, in dilated cardiomyopathy among women of reproductive age.

Clinical Trial Description

Heart failure (HF) is a progressively deteriorating medical condition that significantly reduces both patients' life expectancy and quality of life. Dilated cardiomyopathy (DCM) is one of the leading causes of heart failure in younger adults. Despite many progresses made in the past decades in the development of novel pharmacological treatments for HF, proper management of HF is still challenging and there remains a substantial unmet need in treating heart failure. Bromocriptine, an inhibiter of prolactin release by dopamine-D2-receptor, has been studied in the context of heart failure, and some studies have demonstrated its beneficial role in women with peripartum cardiomyopathy (PPCM). Prolactin level may also increase in of women reproductive-age, in which bromocriptine could also be a good candidate to use of in women of all reproductive ages. Although reports show beneficial role of bromocriptine in improving the left ventricular function in some patients with heart failure, the results may not be applicable to a wide range of populations and patients due to various sources of variation between populations. Thus, it would be relevant to conduct rigorous clinical trial to show the efficacy and safety of this treatment option in diverse populations like Ethiopians. It has been established that the same dose of a medication is associated with considerable heterogeneity in pharmacokinetics (PK) and pharmacodynamic (PD) efficacy and toxicity across human populations. This inter-individual difference in drug response can be explained by pharmacogenetic variations or other factors such as variations in patients' age and weight, co-morbidity, lifestyle, co-medication, renal and liver function, unfavorable drug-drug interactions and poor compliance of patients. The pharmacokinetics (PK) of bromocriptine in heart failure patients, the inter-individual variability in PK and clinical response and associated sources of variations have not been investigated before. Thus, this study is designed to investigate the effectiveness of bromocriptine in terms of efficacy and safety as well as the PK of bromocriptine among women of reproductive age with DCM in Ethiopia. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

• NCT number: NCT06250257
• Study type: Interventional
• Source: Jimma University
• Contact: Kedir N Tukeni, MD
• Phone: +251913521475
• Email: Kedir.negesso@ju.edu.et
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Completion date: August 30, 2024