Angiotensin-II Blockade in Mitral Regurgitation
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Diseases; Mitral Valve Insufficiency
Intervention: Candesartan (Drug); Ramipril (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Maurice Enriquez-Sarano, Affiliation: Mayo Clinic Foundation
Summary
To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral
regurgitation.
Clinical Details
Study design: Randomized, Double-Blind, Placebo Control
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
Minimum age: 21 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
No eligibility criteria
Locations and Contacts
Additional Information
Related publications: Thomson HL, Basmadjian AJ, Rainbird AJ, Razavi M, Avierinos JF, Pellikka PA, Bailey KR, Breen JF, Enriquez-Sarano M. Contrast echocardiography improves the accuracy and reproducibility of left ventricular remodeling measurements: a prospective, randomly assigned, blinded study. J Am Coll Cardiol. 2001 Sep;38(3):867-75. Avierinos JF, Brown RD, Foley DA, Nkomo V, Petty GW, Scott C, Enriquez-Sarano M. Cerebral Ischemic Events After Diagnosis of Mitral Valve Prolapse. A Community-Based Study of Incidence and Predictive Factors. Stroke. 2003 May 8 [epub ahead of print] Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. Grigioni F, Detaint D, Avierinos JF, Scott C, Tajik J, Enriquez-Sarano M. Contribution of ischemic mitral regurgitation to congestive heart failure after myocardial infarction. J Am Coll Cardiol. 2005 Jan 18;45(2):260-7. Messika-Zeitoun D, Aubry MC, Detaint D, Bielak LF, Peyser PA, Sheedy PF, Turner ST, Breen JF, Scott C, Tajik AJ, Enriquez-Sarano M. Evaluation and clinical implications of aortic valve calcification measured by electron-beam computed tomography. Circulation. 2004 Jul 20;110(3):356-62. Epub 2004 Jul 12.
Starting date: April 2001
Ending date: March 2005
Last updated: December 21, 2005
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