A pilot study of 551 elderly patients with isolated systolic hypertension demonstrated the feasibility of recruitment, compliance, and blood pressure control in a placebo-controlled randomized trial.
RCT (n=551)
Does antihypertensive therapy improve blood pressure control and trial feasibility in elderly subjects with isolated systolic hypertension?
The SHEP pilot study demonstrated the feasibility of conducting long-term randomized trials in elderly patients with isolated systolic hypertension.
The Systolic Hypertension in the Elderly Program (SHEP) Pilot Study was conducted to determine the feasibility of conducting a long-term placebo-controlled randomized clinical trial in elderly subjects. Enrolled in the study were 551 men and women between the ages of 60 and 90 years with isolated systolic hypertension (SBP greater than or equal to 160 mmHg and DBP less than 90 mmHg). The study showed that it is possible to recruit old and very old subjects into a clinical trial; the elderly are good compliers (drugs and follow-up visits), with some decline after the age of 80; control of blood pressure was accomplished in the large majority of patients; evaluation of side effects represents a potential problem as varied complaints increase with age thus creating difficulties in distinguishing those attributed to the study drug; and finally, cause-specific mortality is probably preferable to all-cause mortality as an end-point in prevention trials of antihypertensive regimens.
Furberg et al. (Mon,) conducted a rct in Isolated systolic hypertension (n=551). Antihypertensive therapy vs. Placebo was evaluated on Feasibility of conducting a long-term placebo-controlled randomized clinical trial. A pilot study of 551 elderly patients with isolated systolic hypertension demonstrated the feasibility of recruitment, compliance, and blood pressure control in a placebo-controlled randomized trial.