Completed

Control of Hypertension by Non-Pharmacologic Means

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What is being tested

diet, sodium-restricted

+ diet, reducing

+ alcohol restriction

BehavioralDrug
Who is being recruted

Cardiovascular Diseases+1

+ Heart Diseases

+ Hypertension

From 40 to 100 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 1980
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 26, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1980

Actual date on which the first participant was enrolled.

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.

NCT00000498
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 26, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Criteria

Men and women with controlled hypertension.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers