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- Title
Comparison of irbesartan vs felodipine in the regression after 1 year of left ventricular hypertrophy in hypertensive patients (The SILVER trial).
- Authors
Cohen, A; Bregman, B; Rosei, E Agabiti; Williams, B; Dubourg, O; Clairefond, P; Brudi, P; Gosse, P; Guéret, P
- Abstract
The SILVER (Study of Irbesartan in Left VEntricular hypertrophy Regression) trial is designed to test the hypothesis that the newly developed angiontensin-II receptor antagonist, irbesartan, will produce a greater reduction in left ventricular (LV) mass than felodipine ER, in a population of hypertensive patients defined by seated diastolic blood pressure (SeDBP) in the range 95-115 mm Hg or seated systolic blood pressure (SeSBP) in the range 160-200 mm Hg. A population of 360 men and women of non-childbearing potential, >18 years of age, with hypertension, newly diagnosed or after a 3-week washout from previous anti-hypertensive or vasodilator therapies, will be randomised at approximately 80-90 European sites. Add-on therapy with hydrochlorothiazide and atenolol will be allowed for blood pressure control. Patients will be studied by two-dimensional and M-mode echocardiography at baseline (central validation of LV hypertrophy), on randomisation day, and after 6 and 12 months randomised therapy. Blinded analysis of echocardiograms will be performed at a central laboratory, which will provide measurements of the LV mass index (LVMI), determined by M-mode readings according to Devereux formula and using the Penn convention. The primary end-point of the study will be the change in LVMI from baseline to 12 months. The study power is 90% to detect differences between groups from baseline of approximately 8 g/m[SUP2].
- Subjects
HYPERTENSION; LEFT heart ventricle; HYPERTROPHY; ANGIOTENSIN-receptor blockers
- Publication
Journal of Human Hypertension, 1998, Vol 12, Issue 7, p479
- ISSN
0950-9240
- Publication type
Article
- DOI
10.1038/sj.jhh.1000621