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

November 25, 2013 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

National Institute on Aging (NIA)

Investigators

  • Merwyn Greenlick, Kaiser Foundation Research Institute
  • Robert McDonald, University of Pittsburgh
  • H. Perry, Washington University School of Medicine
  • Harold Schnaper, University of Alabama at Birmingham
  • James Schoenberger, Rush University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1980

Study Completion (Actual)

May 1, 1983

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18
  • R10HL023914-01 (Other Grant/Funding Number: US NIH Grant Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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