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| Descriptive Information Fields | |||||
| Brief Title † | Systolic Hypertension in the Elderly Program (SHEP) | ||||
| Official Title † | |||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Cardiovascular Diseases Cerebrovascular Disorders Heart Diseases Hypertension |
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| Intervention † | Drug: chlorthalidone Drug: atenolol Drug: reserpine |
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| MEDLINE PMIDs | 3511131, 2905387, 2676266, 2690065, 1825095, 2046107, 2046114, 1753042, 1999373, 1999371, 1999374, 1999375, 1999376, 1999377, 1999369, 1825649, 1999370, 1999372, 8478043, 8222667, 7506007, 8268898, 8921777, 8968014, 8604962, 8964114, 7919093, 8307638, 7963199, 7520210, 7944835, 8721799, 9218667, 9546039, 9660383, 9645829, 10227414, 9554680, 10227413, 10904510, 10695689, 11497197, 15619390 | ||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | June 1984 | ||||
| Completion Date | October 1996 | ||||
| Eligibility Criteria † | Men and women, aged 60 or over, with isolated systolic hypertension. |
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000514 | ||||
| Organization ID | 33 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators †† | National Institute on Aging (NIA) | ||||
| Investigators † |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2005 | ||||
| First Received Date † | October 27, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
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