Angiotensin-II Blockade in Mitral Regurgitation
Summary
To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral regurgitation.
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. Therefore, chronically decreasing MR, protecting LV and LA with vasoactive treatment are major goals of medical therapy. However, effects of chronic oral vasoactive treatment of MR are controversial and uncertain and recent practice guidelines underscored these gaps in knowledge and did not recommend vasoactive treatment of MR. Hence, a trial of treatment of organic MR is needed.
DESIGN NARRATIVE:
A randomized clinical trial, placebo controlled, double-blind, without crossover, of one year oral treatment with potent tissue angiotensin blockade (with one arm using Candesartan [an angiotensin-II receptor antagonist] and one arm using Ramipril [a tissue angiotensin converting enzyme inhibitor] ) titrated to the maximally tolerated dose. The trial was preceded by an acute study to determine tolerance. End-points were measured by Doppler-Echocardiography for quantitation of MR (regurgitant volume) using a combination of three simultaneous methods (quantitative Doppler, two-dimensional echocardiography, proximal flow convergence) and combination of echocardiography and electron beam computed tomography for left ventricular and left atrial volume measurement. This single center study sought to enroll a total of 135 patients. The analysis was based on intention to treat and compared changes in regurgitant volume, left ventricular end-diastolic volume index and left atrial volume measured after one year of treatment with active drugs or placebo.
Study Design
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind
Conditions
Heart Diseases
Intervention
Candesartan, Ramipril
Status
Completed
Source
National Heart, Lung, and Blood Institute (NHLBI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00014846
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:56:56-0400
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Medical and Biotech [MESH] Definitions
Ventricular Outflow Obstruction
Occlusion of the outflow tract in either the LEFT VENTRICLE or the RIGHT VENTRICLE of the heart. This may result from CONGENITAL HEART DEFECTS, predisposing heart diseases, complications of surgery, or HEART NEOPLASMS.
Heart Diseases
Pathological conditions involving the HEART including its structural and functional abnormalities.
American Heart Association
A voluntary organization concerned with the prevention and treatment of heart and vascular diseases.
Endocarditis, Bacterial
Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.
Heart Valve Diseases
Pathological conditions involving any of the various HEART VALVES and the associated structures (PAPILLARY MUSCLES and CHORDAE TENDINEAE).
