Systolic Hypertension in the Elderly Program (SHEP)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Hypertension; Cardiovascular Diseases; Heart Diseases; Cerebrovascular Disorders

Treatments: Drug: chlorthalidone; Drug: atenolol; Drug: reserpine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000514

33

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Men and women, aged 60 or over, with isolated systolic hypertension.