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
  Purpose

To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral regurgitation.


Condition Intervention Phase
Heart Diseases
Mitral Valve Insufficiency
Drug: Candesartan
Drug: Ramipril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2001
Estimated Study Completion Date: March 2005
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. 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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00014846

Sponsors and Collaborators
Investigators
Investigator: Maurice Enriquez-Sarano Mayo Clinic Foundation
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00014846     History of Changes
Other Study ID Numbers: 966
Study First Received: April 11, 2001
Last Updated: December 21, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Diseases
Mitral Valve Insufficiency
Cardiovascular Diseases
Heart Valve Diseases
Ramipril
Candesartan
Candesartan cilexetil
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 20, 2014