Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group.

Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group.
复制标题

预防单纯收缩期高血压卒中的随机临床试验的基本原理和设计。

DOI:
10.1016/0895-4356(88)90024-8
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发表时间:
1988
影响因子:
7.2
通讯作者:
--
中科院分区:
医学2区
文献类型:
--
作者:

文献摘要

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Isolated systolic hypertension (ISH)-ix. high systolic pressure with nonhypertensive (< 90 mmHg) diastolic pressure—is a recognized risk factor for cardiovascular disease among individuals in the age group 60 years and above. This observation suggests that antihypertensive treatment might be beneficial. Results of the Systolic Hypertension in the Elderly Program Pilot Study (SHEP-PS) indicated the feasibility of a full-scale clinical trial on the efficacy of drug treatment of ISH.The Systolic Hypertension in the Elderly Program (SHEP) is a randomized, double-blind, placebo-controlled clinical trial with the primary objective of assessing the effect of drug treatment of ISH—systolic pressure 160–219 mmHg and diastolic pressure <90—on occurrence of fatal and nonfatal stroke. This multicenter clinical trial has a sample size of 4736 participants, with high statistical power to detect a reduction of 32% or more in the study's primary end point during the 4–6 year period of treatment and follow-up. Low dosage chlorthalidone is the main study drug. Further features of the design of SHEP and the trial's organization are described.