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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00014846 |
To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral regurgitation.
Condition | Intervention | Phase |
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Heart Diseases Mitral Valve Insufficiency |
Drug: Candesartan Drug: Ramipril |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 966 |
Study First Received: | April 11, 2001 |
Last Updated: | December 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00014846 History of Changes |
Health Authority: | United States: Federal Government |
Angiotensin II Type 1 Receptor Blockers Candesartan cilexetil Heart Diseases Candesartan Cardiovascular Agents |
Antihypertensive Agents Angiotensin II Ramipril Heart Valve Diseases Mitral Valve Insufficiency |
Angiotensin II Type 1 Receptor Blockers Heart Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses Candesartan Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Heart Valve Diseases Mitral Valve Insufficiency |