Clinical trial NCT00000485: Hypertension Detection and Follow-up Program (HDFP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine the effectiveness of systematic, sustained, antihypertensive therapy in reducing morbidity and mortality from hypertension in a wide spectrum of persons with elevated blood pressure in 14 communities. During its course, the trial also obtained a direct measure of the prevalence, severity, and treatment status of representative white and black populations with high blood pressure in these 14 communities, and obtained an estimate of the extent of attainable reduction of complications of high blood pressure by an organized screening and blood pressure management program.

Detailed description: BACKGROUND:

Published data from the Veterans Administration Cooperative Study of Hypertension demonstrated that reduction in morbidity and mortality could be attained by treating men with fixed diastolic blood pressure over 105 mm Hg. Similar trends occurred for those with fixed diastolic blood pressure between 90 and 104 mm Hg. Results and current trends from other studies supported these findings. However, prior to inception of the Hypertension Detection and Follow-up Program (HDFP), it was not known whether benefits from antihypertensive therapy applied to all hypertensives in the general population and whether making use of existing medical knowledge could significantly reduce morbidity and mortality from hypertension in communities.

Recognizing this need, NHLBI initiated the pilot activities of the HDFP to characterize significant operational, socioeconomic, and motivational factors that would influence the acceptance of antihypertensive therapy in the defined populations within which the controlled clinical trial would take place and to obtain baseline information necessary to the undertaking of the clinical trial, which was to determine whether a practical, intensive, and antihypertensive program could significantly reduce morbidity and mortality in hypertensives in the general population.

The planning of the trial, including the development of a protocol and manual of operations, began in 1971. Between February 1973 and May 1974, 158,906 persons were screened for high blood pressure in 14 communities. A total of 10,940 hypertensive participants were randomized.

The primary hypothesis tested by the trial was that intensive blood pressure control under stepped care for five years could significantly reduce mortality compared with that under referred-care. Stepped-care was the method of treatment in HDFP clinics in which a diuretic was given initially and additional antihypertensive agents were added in a time-structured, stepwise fashion until goal blood pressure was achieved. Referred-care represented referral to private physicians and other community sources of care. Participating in this study were 14 clinical centers, a coordinating center, ECG center, central laboratory, and monitoring laboratory.

The clinical phase of the trial ended in May 1982. The project was extended into 1983 in order to continue the surveillance of mortality and blood pressure control.

DESIGN NARRATIVE:

The trial was a randomized, non-blind, fixed sample trial with single intervention and control groups. The intervention group received stepped care from the clinical trial clinics (see Background, below), while those in the control group were referred to their own physicians. Each community contributed both stepped-care and referred-care participants, but for analysis purposes, the groups were pooled into two groups. The primary endpoint was mortality. The effects of stepped- vs. referred-care were also assessed on intermediate and secondary factors, including nosologic codes of specific causes of mortality, nonfatal myocardial infarction, stroke, hypertensive heart disease, and EKG abnormalities.

Eligibility criteria: Men and women, ages 30-69. Hypertension. Diastolic blood pressure home readings and clinic readings equal to or above 95 mm Hg and 90 mm Hg, respectively.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: C. Hawkins
References:
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