Control of Hypertension by Non-Pharmacologic Means

July 25, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To determine whether blood pressure could be controlled by nutritional-hygienic, non-pharmacologic means in hypertensives treated with drugs in the Hypertension Detection and Follow-up Trial (HDFP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

In the 1970s, many studies had been conducted to control blood pressure in individuals maintained at normotensive levels by the use of weight control and sodium restriction without the concomitant use of anti-hypertensives. The associations between weight, sodium and blood pressure had been well established, but data on the relationship of intervention to blood pressure control had been less so.

DESIGN NARRATIVE:

Patients were randomly assigned to one of three groups. The 95 patients in Group I were advised to control weight, reduce sodium intake, modify dietary and alcohol intake and were removed from pharmacologic treatment. The 44 patients in Group II were removed from pharmacologic treatment, with no other intervention. The 48 patients in Group III were continued on pharmacologic treatment, with no other intervention. The primary endpoint was the proportion in Groups I and II with diastolic blood pressure less than or equal to 90 mm Hg in the absence of antihypertensive drugs. Secondary endpoints were average diastolic and systolic pressures.

The study completion date listed in this record was obtained from the CRISP legacy data.

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

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Men and women with controlled hypertension.

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: Treatment
  • 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

  • Richard Grimm, Mount Sinai Hospital
  • Jeremiah Stamler, Northwestern University

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

April 1, 1980

Study Completion (Actual)

March 1, 1983

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 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

January 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17
  • R01HL024999 (U.S. NIH Grant/Contract)

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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