Hypertension Detection and Follow-up Program (HDFP)

July 11, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • C. Hawkins, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1971

Study Completion (Actual)

May 1, 1982

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (Estimate)

October 28, 1999

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

December 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: HDFP
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
  2. Study Forms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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