Angiotensin-II Blockade in Mitral Regurgitation

Completed · Phase 4 · Has a placebo group

Conditions studied: Mitral Regurgitation

In brief

Mitral regurgitation (MR) is common in the elderly and its prevalence is increasing with the aging of the population. Organic MR, due to primary valvular lesions, initiates a cascade of complications determined by its degree. MR of severe degree is associated with excess mortality and high cardiac morbidity (heart failure, atrial fibrillation). It also causes left ventricular remodeling which induces left ventricular dysfunction, which in turn leads to poor clinical outcome. Surgery can eliminate MR, but carries immediate and long-term risks, especially in the elderly. Therefore, chronically decreasing the degree of MR is a major goal of medical therapy but such an effect is yet unproved because of conflicting results of small and mostly non-randomized series. Our recent preliminary studies suggest that a sustained decrease of degree of MR and improvement of left ventricular remodeling can be achieved with powerful reduction of afterload, obtained in particular with angiotensin-II receptor blockade. Therefore, the present proposal seeks to address gaps of knowledge regarding vasoactive treatment of MR through the verification of the following hypothesis: Hypothesis: Vasoactive therapy using angiotensin-II receptor blocker (Candesartan Cilexetil) weighed against placebo produces a sustained reduction of the consequences of organic MR. The specific aims are that the treatment a) decreases the degree of MR (decreases the regurgitant volume, primary end-point) and b) improves left ventricular remodeling (decreases the end-diastolic volume index, secondary end-point), as compared to placebo.

Key facts

Study ID: NCT00587470
Run by: Mayo Clinic
People needed: 60
Starts: 1998-08-01
Expected to finish: 2001-08-01
Last updated by the study team: 2010-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients:
18 years old or older, with
Mitral regurgitation on the basis of Color flow imaging
Due to organic disease of the mitral valve on the basis of two-dimensional echocardiography
Isolated (no valve disease other than functional tricuspid regurgitation on the basis of Doppler-Echocardiography)
Pure (no mitral stenosis by Doppler echocardiography)
Quantifiable by Doppler-Echocardiographic methods
Of more than mild degree, defined as regurgitant volume * 30 mL/beat
Occurring on native valves
With Two-dimensional echocardiographic imaging allowing assessment of LV remodeling, and
Asymptomatic (or mildly symptomatic but not considered as candidates for immediate surgery by their attending physician).

You may not qualify if…

Associated aortic valve disease (more than trace aortic regurgitation by color flow imaging or mean gradient *25 mmHg)
Associated mitral stenosis (mean gradient* 5 mmHg, valve area < 1.5 cm2)
Associated congenital or pericardial diseases on the basis of Doppler echocardiography
Intolerance to either AII blockers or Angiotensin converting enzyme inhibitors
Intolerance to iodine contrast material
Intolerance to intravenous echographic contrast agents
Renal failure with creatinine * 2 mg/dl
Blood pressure below 100 mmHg
Known renal artery stenosis
Ongoing therapy with hydralazine, calcium-entry blocking drugs or angiotensin converting enzyme inhibitors
Known severe comorbidity such as liver disease, malignancy
Pregnancy (A negative pregnancy test and effective contraceptive methods are required prior to enrollment of females of childbearing potential (not post-menopausal or surgically sterilized)), and
Patients considered as requiring mitral valve surgery by their attending physician or with previous valve repair or replacement.

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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