Systolic Hypertension in Europe Placebo-Controlled Trial
Status:
Terminated
Trial end date:
1997-02-01
Target enrollment:
Participant gender:
Summary
The Syst-Eur Trial is a concerted action of the European Community's Medical and Health
Research Programme. The trial is carried out in consultation with the World Health
Organization, the International Society of Hypertension, the European Society of Hypertension
and the World Hypertension League. Syst-Eur is a multicentre trial designed by the European
Working Party on High Blood Pressure in the Elderly (EWPHE), to test the hypothesis that
antihypertensive treatment of elderly patients with isolated systolic hypertension results in
a significant change in stroke morbidity and mortality. Secondary endpoints include
cardiovascular events, such as myocardial infarction and congestive heart failure. To be
eligible patients must be at least 60 years old and have a systolic blood pressure averaging
160-219 mmHg with a diastolic pressure less than 95 mmHg. Patients must give their informed
consent and be free of major cardiovascular and non-cardiovascular diseases at entry. The
patients are randomized to active treatment or placebo. Active treatment consists of
nitrendipine (10-40 mg/day), combined with enalapril (5-20 mg/day) and hydrochlorothiazide
(12.5-25 mg/day), as necessary. The patients of the control group receive matching placebos.
The drugs (or matching placebos) are stepwise titrated and combined in order to reduce
systolic blood pressure by 20 mmHg at least to a level below 150 mmHg. Morbidity and
mortality are monitored to enable an intention-to-treat and per-protocol comparison of the
outcome in the 2 treatment groups.