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Hypertension Detection and Follow-up Program (HDFP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000485
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Drug: diuretics Drug: antihypertensive agents Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1971
Study Completion Date: May 1982
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000485


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: C. Hawkins University of Texas
  More Information

Publications:
Remington RD On behalf of the HDFP Cooperative Group: The Hypertension Detection and Follow-up Program. Inserm, 21:185-194, 1973.
Hypertension and Education. Journal of the American Dietetic Association, 72 (4):377, April l978. (Summary of Mainstream Paper #5A.)
Blood Pressure Studies in l4 Communities: A Two-Stage Screen for Hypertension. l978 Year Book of Cardiology: 355-57 (Summary of Mainstream Paper #2.)
Borhani N: The Hypertension Detection and Follow-Up Program, in Onesti G and Klimt C (eds), Hypertension. Determinants, Complications, and Intervention, Grune & Stratton, New York, pp. 405-4l4, l979.
Stamler J, Borhani NO: Interview: HDFP Mortality and Morbidity. Hypertension Report, 1(l):l2-l4, l980.
Stamler J: Clinical Ramifications of the Hypertension Detection and Follow-up Program: Benefits of Treatment Outweigh Risks. Symposia Reporter, 4(2):l2-l4, May l980.
Langford HG: Clinical Ramifications of the Hypertension Detection and Follow-up Program: HDFP Methodology and Results: Overview. Symposia Reporter, 4(2):3-6, May l980.
Borhani NO: Clinical Ramifications of the Hypertension Detection and Follow-up Program: SC Yields Lower Mortality and Morbidity. Symposia Reporter, 4(2):l6, May l980.
Tyroler HA: Race, Education and Five-Year Mortality In HDFP Stratum I Referred-care Males in Mild Hypertension: Recent Advances, Gross R and Strasser T (Eds). New York, Raven Press, 163- , 1983.
Heyden S, Tyroler HA, Hames G, et al: Diet Treatment of Obese Hypertensives. Clinical Science and Molecular Medicine, 45:2095-2125, 1973.
Schlant RC, Felner JL, Heymsfield SB, Gilbert CA, Shulman NB, Tuttle EP, and Blumenstein BA: Echocardiography and Essential Hypertension. Cardiovascular Medicine, 2:477-490, l977.
Smith EO, Hardy RJ, Cutter GR, Curb JD, and Hawkins CM: Application of Survival Analysis Techniques to Evaluation of Factors Affecting Compliance in a Clinical Trial of Hypertension Control. Controlled Clin Trials, l:59-69, l980.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: HDFP
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.

ClinicalTrials.gov Identifier: NCT00000485     History of Changes
Other Study ID Numbers: 4
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
Last Verified: December 2005

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Diuretics
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs