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Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000499
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
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 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.


Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Drug: chlorthalidone Drug: reserpine Drug: hydralazine Drug: metoprolol Phase 2

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

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

Study Start Date: September 1980
Study Completion Date: May 1983
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg.
  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): NCT00000499


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Investigators
OverallOfficial: Merwyn Greenlick Kaiser Foundation Research Institute
OverallOfficial: Robert McDonald University of Pittsburgh
OverallOfficial: H. Perry Washington University School of Medicine
OverallOfficial: Harold Schnaper University of Alabama at Birmingham
OverallOfficial: James Schoenberger Rush University
  More Information

Publications:
Smith WM: Isolated Systolic Hypertension in the Elderly. Curr Med Res Opin, 8:19-29, 1983.
Hughes GH, Schnaper HW: The Systolic Hypertension in the Elderly Program. Int J Mental Health, 11:76-97, 1983.
Smith WM: Isolated Systolic Hypertension in the Elderly. Mild Hypertension: Recent Advances, Raven Press, New York, 1983.

ClinicalTrials.gov Identifier: NCT00000499     History of Changes
Other Study ID Numbers: 18
R10HL023914-01 ( Other Grant/Funding Number: US NIH Grant Number )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
Last Verified: April 2012

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Metoprolol
Chlorthalidone
Hydralazine
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
Vasodilator Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Adrenergic Uptake Inhibitors