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Systolic Hypertension in the Elderly Program (SHEP)

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ClinicalTrials.gov Identifier: NCT00000514
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 15, 2016
National Institute on Aging (NIA)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cerebrovascular Disorders Heart Diseases Hypertension Drug: chlorthalidone Drug: atenolol Drug: reserpine Phase 3

Detailed Description:


More than 3 million persons in the United States over the age of 60 have isolated systolic hypertension. They face an excess risk (2-3 fold) of stroke, other cardiovascular disease and death. Population-based data show that the prevalence rises from approximately 8 percent in the age group 60-69 years to approximately 20 percent over the age of 80. Based on available data, an annual stroke rate of 2.0 percent has been estimated in this population. The full-scale clinical trial followed a pilot study conducted from 1980 to 1983. Recruitment in the trial began in March 1985 and was finished in January 1988. Follow-up ended in February 1991. Data analysis continued through October 1996.


A randomized, double-blind trial in which 2,365 subjects were assigned to active treatment and 2,371 to placebo. For the active treatment group, a stepped-care regimen was used which included chlorthalidone 12.5 or 25 mg/day, and as needed, addition of atenolol 25 or 50 mg/day or reserpine, 0.05 or 0.10 mg/day. Treatment goal was to reduce systolic blood pressure by at least 20 mm Hg from baseline and to below 160 mm Hg with minimal amounts of study medication. The primary endpoint was the incidence of fatal and non-fatal stroke. Secondary endpoints were cardiovascular and coronary morbidity and mortality, all-cause mortality, and quality-of-life measures.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : June 1984
Study Completion Date : October 1996

Resource links provided by the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Men and women, aged 60 or over, with isolated systolic hypertension.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000514

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
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OverallOfficial: C. Hawkins University of Texas
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SHEP
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

Furberg CD, Cutler JA, Probstfield JL, et al: The Systolic Hypertension in the Elderly Program. Mild Hypertension: From Drug Trials to Practice, Raven Press, New York, 59-63, 1987.
Probstfield JL, Applegate WB, Curb JD, et al for the SHEP Cooperative Research Group: The Systolic Hypertension in the Elderly Program (SHEP): Rationale, Design, Recruitment, and Baseline Data. In: Omae T, Zanchetti A, (Eds.) How Should Elderly Hypertensive Patients Be Treated? Tokyo: Springer-Verlag, 135-142, 1989.
Systolic Hypertension in the Elderly Program (SHEP). Baseline Characteristics of the Randomized Participants. Black HR, Curb JD, Pressel S, et al, Guest Editors.

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ClinicalTrials.gov Identifier: NCT00000514    
Other Study ID Numbers: 33
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: January 2005
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants