Hypertension Clinical Trial
The SHEP Pilot Study had six objectives, each designed to develop and test critical
components of a full scale trial directed at the health consequences of treating isolated
systolic hypertension (ISH) in the elderly.
l. To estimate and compare the yield of participants for randomization into a clinical trial
from various community groups using various recruitment techniques.
2. To estimate compliance with the visit schedule and to the prescribed double-blind
regimens.
3. To estimate and compare the effectiveness of specified antihypertensive medications in
reducing the blood pressure.
4. To estimate and compare the unwanted effects of specified antihypertensive medication in
an elderly population.
5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this
population.
6. To develop and test methods of ascertaining stroke and other disease endpoints.
BACKGROUND:
Isolated systolic hypertension, defined as systolic blood pressure of 140 mm Hg or greater
with a diastolic blood pressure below 90 mm Hg, is known to be associated with an increase
of risk of coronary heart disease and stroke. The HANES I group estimated that isolated
systolic hypertension, uncommon under 54 years of age, occurred in 5 percent to 10 percent
of adults over 55 years and was less common than systolic-diastolic elevation. Evidence was
not readily available that there was effective and safe therapy to correct isolated systolic
hypertension. At that time, there was no body of clinical or research data that conclusively
proved that such therapy, if available, was beneficial.
Several groups had expressed interest in a clinical trial on systolic hypertension in the
elderly. Among these were the House Select Committee on Aging, a Blue-Ribbon Panel on
Hypertension in the Elderly, Citizens for the Treatment of High Blood Pressure, panels and
experts associated with the National High Blood Pressure Education Program, the National
Institute on Aging, the National Institute of Mental Health, and the National Institute of
Neurological and Communicative Disorders and Stroke.
A Policy and Data Monitoring Board was appointed to review the protocols for the pilot
studies as they developed and make recommendations to the Director of NHLBI. The Policy and
Data Monitoring Board reviewed the accumulated data on April 8, 1983 and recommended to the
Institute that a full scale trial be implemented. The recommendation was accepted by the
Director, NHLBI and was presented to the National Heart, Lung, and Blood Advisory Council at
its meeting in May 1983. A full scale trial was conducted.
DESIGN NARRATIVE:
A randomized, double-blind design, with two groups and fixed sample size. The 551
participants were randomized in a stratified double-blind manner to either chlorthalidone or
matching placebo in a ratio of 4:l. Subjects failing to reach goal blood pressure were
randomized a second time to receive one of the following drugs in addition to
chlorthalidone: reserpine, hydralazine, and metoprolol. Subjects on placebo in Step I who
did not achieve goal had a corresponding Step II placebo added to their regimen.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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