Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000499
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Systolic Hypertension in the Elderly Program SHEP Pilot Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 4l 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
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 4l 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R10HL023914-01 | OTHER_GRANT | US NIH Grant Number | None |