Comparison of irbesartan vs felodipine in the regression after 1 year of left ventricular hypertrophy in hypertensive patients (the SILVER trial). Study of Irbesartan in Left VEntricular hypertrophy Regression

J Hum Hypertens. 1998 Jul;12(7):479-83. doi: 10.1038/sj.jhh.1000621.

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 mmHg 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/m2.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antihypertensive Agents / therapeutic use*
  • Biphenyl Compounds / therapeutic use*
  • Blood Pressure / drug effects
  • Calcium Channel Blockers / therapeutic use*
  • Double-Blind Method
  • Echocardiography
  • Felodipine / therapeutic use*
  • Female
  • Follow-Up Studies
  • Humans
  • Hypertension / complications
  • Hypertension / diagnostic imaging
  • Hypertension / drug therapy*
  • Hypertrophy, Left Ventricular / diagnostic imaging
  • Hypertrophy, Left Ventricular / drug therapy*
  • Hypertrophy, Left Ventricular / etiology
  • Irbesartan
  • Male
  • Tetrazoles / therapeutic use*
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Biphenyl Compounds
  • Calcium Channel Blockers
  • Tetrazoles
  • Irbesartan
  • Felodipine