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Systolic Hypertension in the Elderly Program (SHEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000514
First Posted: October 28, 1999
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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 Intervention Phase
Cardiovascular Diseases Cerebrovascular Disorders Heart Diseases Hypertension Drug: chlorthalidone Drug: atenolol Drug: reserpine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1984
Estimated Study Completion Date: October 1996
Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, aged 60 or over, with isolated systolic hypertension.
  Contacts and Locations
Information from the National Library of Medicine

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)
Investigators
OverallOfficial: C. Hawkins University of Texas
  More Information

Publications:
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.

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.

ClinicalTrials.gov Identifier: NCT00000514     History of Changes
Other Study ID Numbers: 33
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: April 15, 2016
Last Verified: January 2005

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Cerebrovascular Disorders
Vascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atenolol
Chlorthalidone
Reserpine
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
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
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants