Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250257
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-02-01
Brief Title:
Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age
Sponsor:
Jimma University
Organization:
Jimma University
Study Overview
Official Title:
Effectiveness of Bromocriptine in Dilated Cardiomyopathy Among Women of Reproductive Age A Hospital-Based Randomized Open Label Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None