Angiotensin-II Blockade in Mitral Regurgitation

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00014846
First received: April 11, 2001
Last updated: December 21, 2005
Last verified: December 2005

April 11, 2001
December 21, 2005
April 2001
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Complete list of historical versions of study NCT00014846 on ClinicalTrials.gov Archive Site
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Angiotensin-II Blockade in Mitral Regurgitation
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To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral regurgitation.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
  • Heart Diseases
  • Mitral Valve Insufficiency
  • Drug: Candesartan
  • Drug: Ramipril
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2005
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No eligibility criteria

Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00014846
966
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Maurice Enriquez-Sarano Mayo Clinic Foundation
National Heart, Lung, and Blood Institute (NHLBI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP