Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166400
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2005-09-12
Brief Title:
A Randomized Clinical Trial of Metoprolol in Participants With Mitral Regurgitation
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Beta Blockade in Mitral Regurgitation
Status:
COMPLETED
Status Verified Date:
2008-07
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:
Mitral valve regurgitation leakage of the mitral valve of the heart is frequent and currently there is no specific medical therapy Mitral regurgitation is a slowly progressive disease that frequently requires surgical treatment This randomized clinical trial will use Metoprolol a common beta-blocker medication to determine if medical treatment impacts mitral valve disease progression
Detailed Description:
Background Mitral regurgitation MR is frequent and its prevalence is increasing with aging of the population Organic MR due to primary valvular lesions has severe consequences determined by its degree with left ventricular LV remodeling and dysfunction left atrial LA enlargement leading to poor clinical outcome Surgery can eliminate MR but carries notable risks and is not applicable to all patients Recent animal data suggest that beta-blockade in organic MR has significant positive effect particularly on LV remodeling Therefore chronically decreasing MR protecting LV and LA with beta-blockade are major goals of medical therapy However effects of chronic oral beta-blockade of human MR are uncertain and recent practice guidelines underscored these gaps in knowledge and did not recommend beta-blockade of MR Hence a trial of treatment of organic MR is needed A large trial with mortality-morbidity end-points is desirable but premature without knowledge of magnitude of mechanistic effects of beta-blockade The improvement of these intermediate end-points mechanistically linked to outcome is measurable with non-invasive quantitative techniques and forms the basis of the present clinical trial proposal Hypothesis Chronic beta-blockade therapy using Metoprolol weighed against placebo produces a sustained reduction of the consequences of organic MR Specific aims are that treatment improves a degree of MR decreases regurgitant volume primary end-point b LV remodeling decreases LV end-diastolic volume index second end-point and c LA enlargement decreases LA volume third end-point as compared to placebo Population Patients with MR organic intrinsic valve disease isolated no other valve disease d moderate regurgitant volume 30 mLbeat Methods A randomized clinical trial placebo controlled double-blind without crossover of 12 months oral treatment with potent beta-blockade Metoprolol XL 50 to 200mg QD titrated to the maximally tolerated dose The trial is preceded by an acute study to determine tolerance End-points are measured by Doppler-Echocardiography for quantitation of MR regurgitant volume using combination of 3 simultaneous methods quantitative Doppler two-dimensional echocardiography proximal flow convergence and echocardiography for LV and LA volume measurement In addition cardiopulmonary exercise testing will measure peak O2 consumption at baseline and follow-up This study seeks to enroll a total of 60 patients The analysis will be based on intention to treat and compare changes in regurgitant volume LV end-diastolic volume index and LA volume measured after one year of treatment with active drug or placebo The results of this clinical trial should provide strong evidence regarding medical treatment of patients with organic MR and define future strategies to minimize mortality and morbidity of organic MR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRUSMETO0047 IRB 960-04 | None | None | None |