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

NCT00000499 | Completed Phase 2

• 2 other identifiers: 18R10HL023914-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Interventions

chlorthalidone DRUG

reserpine DRUG

hydralazine DRUG

metoprolol DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• National Institute on Aging (NIA): collaborator

Related Publications (10)

• Smith WM: Isolated Systolic Hypertension in the Elderly. Curr Med Res Opin, 8:19-29, 1983.

  BACKGROUND

• Hughes GH, Schnaper HW: The Systolic Hypertension in the Elderly Program. Int J Mental Health, 11:76-97, 1983.

  BACKGROUND

• Smith WM: Isolated Systolic Hypertension in the Elderly. Mild Hypertension: Recent Advances, Raven Press, New York, 1983.

  BACKGROUND

• 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.

  PMID: 4072925 BACKGROUND

• 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.

  PMID: 3956210 BACKGROUND

• 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.

  PMID: 3511131 BACKGROUND

• 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.

  PMID: 3302150 BACKGROUND

• 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.

  PMID: 3303916 BACKGROUND

• 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.

  PMID: 3293631 BACKGROUND

• 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.

  PMID: 2911834 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Interventions

Chlorthalidone; Reserpine; Hydralazine; Metoprolol

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Yohimbine; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1980
• Study Completion: May 1, 1983
• Last Updated: November 26, 2013

Record last verified: 2012-04