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Hypertension Detection and Follow-up Program (HDFP)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diuretics
antihypertensive agents
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    July 11, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000485
    Brief Title
    Hypertension Detection and Follow-up Program (HDFP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1971 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 1982 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    diuretics
    Intervention Type
    Drug
    Intervention Name(s)
    antihypertensive agents

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    C. Hawkins
    Organizational Affiliation
    University of Texas

    12. IPD Sharing Statement

    Citations:
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    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    http://biolincc.nhlbi.nih.gov/studies/hdfp/
    Available IPD/Information Identifier
    HDFP
    Available IPD/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.
    Available IPD/Information Type
    Study Forms
    Available IPD/Information URL
    http://biolincc.nhlbi.nih.gov/studies/hdfp/

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    Hypertension Detection and Follow-up Program (HDFP)

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