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Control of Hypertension by Non-Pharmacologic Means

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, sodium-restricted
diet, reducing
alcohol restriction
antihypertensive agents
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men and women with controlled hypertension.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    July 25, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000498
    Brief Title
    Control of Hypertension by Non-Pharmacologic Means
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1980 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1983 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    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).
    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.

    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
    Treatment
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, sodium-restricted
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, reducing
    Intervention Type
    Behavioral
    Intervention Name(s)
    alcohol restriction
    Intervention Type
    Drug
    Intervention Name(s)
    antihypertensive agents

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women with controlled hypertension.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Grimm
    Organizational Affiliation
    MOUNT SINAI HOSPITAL
    First Name & Middle Initial & Last Name & Degree
    Jeremiah Stamler
    Organizational Affiliation
    Northwestern University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3903735
    Citation
    Stamler R, Stamler J, Grimm R, Dyer A, Gosch FC, Berman R, Elmer P, Fishman J, Van Heel N, Civinelli J, et al. Nonpharmacological control of hypertension. Prev Med. 1985 May;14(3):336-45. doi: 10.1016/0091-7435(85)90060-x.
    Results Reference
    background
    PubMed Identifier
    3546747
    Citation
    Stamler R, Stamler J, Grimm R, Gosch FC, Elmer P, Dyer A, Berman R, Fishman J, Van Heel N, Civinelli J, et al. Nutritional therapy for high blood pressure. Final report of a four-year randomized controlled trial--the Hypertension Control Program. JAMA. 1987 Mar 20;257(11):1484-91. doi: 10.1001/jama.257.11.1484.
    Results Reference
    background
    PubMed Identifier
    3653970
    Citation
    Dyer AR, Stamler R, Grimm R, Stamler J, Berman R, Gosch FC, Emidy LA, Elmer P, Fishman J, Van Heel N, et al. Do hypertensive patients have a different diurnal pattern of electrolyte excretion? Hypertension. 1987 Oct;10(4):417-24. doi: 10.1161/01.hyp.10.4.417.
    Results Reference
    background
    PubMed Identifier
    2645845
    Citation
    Stamler R, Grimm RH Jr, Dyer AR, Talano JV, Prineas R, Crow R, Berman R, Gosch FC, Elmer P, Stamler J. Cardiac status after four years in a trial on nutritional therapy for high blood pressure. Arch Intern Med. 1989 Mar;149(3):661-5.
    Results Reference
    background
    PubMed Identifier
    2454254
    Citation
    McDonald AM, Dyer AR, Liu K, Stamler R, Gosch FC, Grimm R, Berman R, Stamler J. Sodium, lithium-countertransport and blood pressure control by nutritional intervention in 'mild' hypertension. J Hypertens. 1988 Apr;6(4):283-91.
    Results Reference
    background

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    Control of Hypertension by Non-Pharmacologic Means

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