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Home > "S" Clinical Trials Conditions > Systolic Hypertension in the Elderly Program (SHEP)  Systolic Hypertension in the Elderly Program (SHEP)
Systolic Hypertension in the Elderly Program (SHEP)
For Condition: Cardiovascular Diseases,Cerebrovascular Disorders,Heart Diseases,Hypertension
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) , National Institute on Aging (NIA)
Synopsis: The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
Details: BACKGROUND: More than 3 million persons in the United States over the age of 60 have isolated systolic hypertension. They face an excess risk (2-3 fold) of stroke, other cardiovascular disease and death. Population-based data show that the prevalence rises from approximately 8 percent in the age group 60-69 years to approximately 20 percent over the age of 80. Based on available data, an annual stroke rate of 2.0 percent has been estimated in this population. The full-scale clinical trial followed a pilot study conducted from 1980 to 1983. Recruitment in the trial began in March 1985 and was finished in January 1988. Follow-up ended in February 1991. Data analysis continued through October 1996. DESIGN NARRATIVE: A randomized, double-blind trial in which 2,365 subjects were assigned to active treatment and 2,371 to placebo. For the active treatment group, a stepped-care regimen was used which included chlorthalidone 12.5 or 25 mg/day, and as needed, addition of atenolol 25 or 50 mg/day or reserpine, 0.05 or 0.10 mg/day. Treatment goal was to reduce systolic blood pressure by at least 20 mm Hg from baseline and to below 160 mm Hg with minimal amounts of study medication. The primary endpoint was the incidence of fatal and non-fatal stroke. Secondary endpoints were cardiovascular and coronary morbidity and mortality, all-cause mortality, and quality-of-life measures.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: Men and women, aged 60 or over, with isolated systolic hypertension.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardAllman, , University of Alabama
Additional Information:
Study ID Numbers: 33;
Study Start Date: June 1984
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000514
Other Cardiovascular Diseases Studies:
1. Trial of Antihypertensive Intervention Management
2. Harvard Atherosclerosis Reversibility Project (HARP)
3. Framingham Cycle V Offspring-Spouse Nutrition Studies
4. CVD Nutrition Education
5. National Growth and Health Study (NGHS)
Related Studies:
Other Cardiovascular Diseases Clinical Trials
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Systolic Hypertension in the Elderly Program (SHEP)
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