Systolic Hypertension in the Elderly Program (SHEP)
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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.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Cerebrovascular Disorders Heart Diseases Hypertension |
Drug: chlorthalidone Drug: atenolol Drug: reserpine |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
Study Start Date: | June 1984 |
Estimated Study Completion Date: | October 1996 |
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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women, aged 60 or over, with isolated systolic hypertension.
Publications:
ClinicalTrials.gov Identifier: | NCT00000514 History of Changes |
Other Study ID Numbers: | 33 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
Cardiovascular Diseases Cerebrovascular Disorders Heart Diseases Hypertension Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Atenolol Chlorthalidone Reserpine Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Diuretics Natriuretic Agents |
ClinicalTrials.gov processed this record on February 24, 2013