Clinical trial NCT00000499: Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: National Institute on Aging (NIA)
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Foundation Research Institute
name: Merwyn Greenlick
affiliation: University of Pittsburgh
name: Robert McDonald
affiliation: Washington University School of Medicine
name: H. Perry
affiliation: University of Alabama at Birmingham
name: Harold Schnaper
affiliation: Rush University
name: James Schoenberger
References:
citation: Smith WM: Isolated Systolic Hypertension in the Elderly. Curr Med Res Opin, 8:19-29, 1983.
citation: Hughes GH, Schnaper HW: The Systolic Hypertension in the Elderly Program. Int J Mental Health, 11:76-97, 1983.
citation: Smith WM: Isolated Systolic Hypertension in the Elderly. Mild Hypertension: Recent Advances, Raven Press, New York, 1983.
citation: Hulley SB, Furberg CD, Gurland B, McDonald R, Perry HM, Schnaper HW, Schoenberger JA, Smith WM, Vogt TM. Systolic Hypertension in the Elderly Program (SHEP): antihypertensive efficacy of chlorthalidone. Am J Cardiol. 1985 Dec 1;56(15):913-20. doi: 10.1016/0002-9149(85)90404-7.
citation: Bagniewska A, Black D, Molvig K, Fox C, Ireland C, Smith J, Hulley S. Data quality in a distributed data processing system: the SHEP Pilot Study. Control Clin Trials. 1986 Mar;7(1):27-37. doi: 10.1016/0197-2456(86)90005-x.
citation: Hulley SB, Feigal D, Ireland C, Kuller LH, Smith WM. Systolic hypertension in the elderly program (SHEP). The first three months. J Am Geriatr Soc. 1986 Feb;34(2):101-5. doi: 10.1111/j.1532-5415.1986.tb05476.x. No abstract available.
citation: Perry HM Jr, McDonald RH, Hulley SB, Smith WM, Furberg CD, Greenlick MR, Kuller LH, Schnaper HW, Schoenberger JA, Vogt TM. Systolic Hypertension in the Elderly Program, Pilot Study (SHEP-PS): morbidity and mortality experience. J Hypertens Suppl. 1986 Dec;4(6):S21-3.
citation: Siegel D, Kuller L, Lazarus NB, Black D, Feigal D, Hughes G, Schoenberger JA, Hulley SB. Predictors of cardiovascular events and mortality in the Systolic Hypertension in the Elderly Program pilot project. Am J Epidemiol. 1987 Sep;126(3):385-99. doi: 10.1093/oxfordjournals.aje.a114670.
citation: Vogt TM, Ireland CC, Greenlick MR, Hughes GH. Relation of life events to blood pressure control in the SHEP pilot trial. Am J Prev Med. 1988 Jan-Feb;4(1):1-4.
citation: Perry HM Jr, Smith WM, McDonald RH, Black D, Cutler JA, Furberg CD, Greenlick MR, Kuller LH, Schnaper HW, Schoenberger JA, et al. Morbidity and mortality in the Systolic Hypertension in the Elderly Program (SHEP) pilot study. Stroke. 1989 Jan;20(1):4-13. doi: 10.1161/01.str.20.1.4.