Cardiovascular DiseasesPhase 2NCT00000499
Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)
A Phase 2 study testing chlorthalidone, reserpine and hydralazine in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- chlorthalidone, reserpine and hydralazine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1980to May 1983
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg.
About this study
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.
- To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques.
- To estimate compliance with the visit schedule and to the prescribed double-blind regimens.
- To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure.
- To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population.
- To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population.
- To develop and test methods of ascertaining stroke and other disease endpoints.
Read the 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.
- Being tested
- chlorthalidone, reserpine, hydralazine, metoprolol
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorthalidoneDrug
reserpineDrug
hydralazineDrug
metoprololDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1980
- Study completionMay 1983
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Merwyn Greenlick, Kaiser Foundation Research InstituteRobert McDonald, University of PittsburghH. Perry, Washington University School of MedicineHarold Schnaper, University of Alabama at BirminghamJames Schoenberger, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000499
- Sponsor's protocol ID
- 18
- Other IDs
- R10HL023914-01
- Status last verified
- Apr 2012
- First submitted
- 27 Oct 1999
- Last updated
- 26 Nov 2013
- Results posted
- No
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.
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.
PubMed 4072925Bagniewska 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.
PubMed 3956210Hulley 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.
PubMed 3511131Perry 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.
PubMed 3302150Siegel 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.
PubMed 3303916Vogt 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.
PubMed 3293631Perry 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.
PubMed 2911834
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)
- ClinicalTrials.gov ID
- NCT00000499
- Acronym / sponsor ID
- 18
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 1980
- Study completion
- May 1983 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques.
- To estimate compliance with the visit schedule and to the prescribed double-blind regimens.
- To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure.
- To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population.
- To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlorthalidone | Drug | – |
| reserpine | Drug | – |
| hydralazine | Drug | – |
| metoprolol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- BackgroundSmith WM: Isolated Systolic Hypertension in the Elderly. Curr Med Res Opin, 8:19-29, 1983.
- BackgroundHughes GH, Schnaper HW: The Systolic Hypertension in the Elderly Program. Int J Mental Health, 11:76-97, 1983.
- BackgroundSmith WM: Isolated Systolic Hypertension in the Elderly. Mild Hypertension: Recent Advances, Raven Press, New York, 1983.
- Background: PubMed 4072925Hulley 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.
- Background: PubMed 3956210Bagniewska 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.
- Background: PubMed 3511131Hulley 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.
- Background: PubMed 3302150Perry 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.
- Background: PubMed 3303916Siegel 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.
- Background: PubMed 3293631Vogt 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.
- Background: PubMed 2911834Perry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merwyn Greenlick
Kaiser Foundation Research Institute
Robert McDonald
University of Pittsburgh
H. Perry
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chlorthalidone, reserpine and hydralazine in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000499, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013; AzTrials last refreshed its copy on 30 Oct 2026.