SYSTOLIC HYPERTENSION IN THE ELDERLY - LONG-TERM LACIDIPINE TREATMENT- OBJECTIVE, PROTOCOL, AND ORGANIZATION

Isolated systolic hypertension (ISH) is a definite risk factor for car diovascular complications (i.e., cardiac failure, coronary artery dise ase, and stroke) independent of diastolic elevation. The prevalence of ISH is estimated to be approximately 15-20% in the population above t he age of 60 years, and increases with advancing age. The Systolic Hyp ertension in the Elderly (SHELL) study is planned to evaluate the effi cacy and tolerability of lacidipine, matched with the diuretic chlorth alidone, in treatment of ISH in elderly hypertensive patients (EHP). O ne hundred fifteen Italian centers will participate in the study. Fift y centers are associated with the Societa Italiana di Geriatria Ospeda liera and 65 centers are departments of internal medicine or outpatien t clinics for management of hypertension, A total of 4,800 patients wi ll be enrolled in the trial. Two subprojects will consist of periodica l echocardiographic evaluation and 24-h ambulatory blood pressure moni toring, The primary end point of the SHELL study is the incidence of c ardiovascular and cerebrovascular events in EHP with ISH, treated with either lacidipine or chlorthalidone. In particular, the SHELL trial i s intended to determine whether lacidipine treatment will significantl y reduce fatal myocardial events and total cardiovascular mortality.