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Dietary Intervention Study for Hypertension (DISH)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, sodium-restricted
diet, reducing
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

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

Men and women with hypertension. Diastolic blood pressure equal to or above 95 mm Hg and 90 mm Hg, respectively for home and clinic readings.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    April 14, 2015
    Sponsor
    University of Mississippi Medical Center
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000497
    Brief Title
    Dietary Intervention Study for Hypertension (DISH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1980 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1994 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Mississippi Medical Center
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    The primary objective of this multicenter cooperative clinical trial was to determine if dietary modification would enable drug controlled hypertensive patients to remain at 'goal blood pressures' after antihypertensive medication was withdrawn. The proposal made use of the HDFP hypertensive population who had five years of treatment for their hypertension. Additionally, the group of investigators proposed to determine if dietary treatment would permit patients not previously adequately controlled under the HDFP program to achieve normalization of blood pressure with a combination of dietary modification and drug treatment. The study also proposed to search for predictors (i.e., levels of hormonal agents such as plasma renin activity) of responsiveness to dietary manipulation among the hypertensive population as well as to identify psychological attributes that might be of importance in managing these patients.
    Detailed Description
    BACKGROUND: The background against which the proposal was made had been developed from the combined information of the Veterans Administration Cooperative Study and the Hypertension Detection and Follow-up Study. Data from both these studies clearly established the importance of reducing sodium content by means of diuretic administration as a mainstay of the treatment of elevated blood pressure. The risks of the lifetime of treatment were undefined, but the cost of indefinite treatment of high blood pressure was sufficiently high to stimulate careful examination of alternative modes of management of such patients. The demonstrations by Parijs and others that moderate reduction in sodium intake led to improved management of hypertension and data suggesting that increased potassium intake may enhance this blood pressure lowering effect associated with sodium restriction was cited by the investigators as a basis for the trial. Any additional data regarding modest sodium restriction and potassium ingestion would have impact on utilizing such therapy in preventing hypertension and as adjunctive therapy. DESIGN NARRATIVE: The study was intended to take advantage of the availability of patients at the three centers at the completion of the Hypertension Detection and Follow-up Program Study. These patients were enrolled as 'stepped-care' participants and had been treated with antihypertensive drugs for at least five years. The main objective of the study was to determine the contribution of dietary modification to maintenance of normal blood pressure after withdrawal of medication. Two types of diet change were followed: 1) reduction of sodium intake coupled with increased potassium intake; and 2) reduction of weight in the subgroups of patients that were obese.

    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women with hypertension. Diastolic blood pressure equal to or above 95 mm Hg and 90 mm Hg, respectively for home and clinic readings.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Herbert Langford
    Organizational Affiliation
    University of Mississippi Medical Center

    12. IPD Sharing Statement

    Citations:
    Citation
    Wassertheil-Smoller S, Langford HG, Blaufox, MD, et al: Rate of Hypertension Return After Withdrawal of Prolonged Antihypertensive Therapy. Clin Sci, 63: 423S-525S (Supp 8), 1982.
    Results Reference
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    PubMed Identifier
    6342972
    Citation
    Wassertheil-Smoller, Langford HG, Blaufox MD, Oberman A, Hawkins M. Diuretics and salt restriction in blood pressure control. Curr Concepts Nutr. 1983;12:175-89. No abstract available.
    Results Reference
    background
    Citation
    Langford HG, Blaufox, MD, Oberman A, et al: Effect of Weight Loss on the Return of Hypertension After Withdrawal of Prolonged Antihypertensive Therapy. Nutritional Prevention of Cardiovascular Disease, 301-315, 1984.
    Results Reference
    background
    PubMed Identifier
    6494106
    Citation
    Wing RR, Caggiula AW, Nowalk MP, Koeske R, Lee S, Langford H. Dietary approaches to the reduction of blood pressure: the independence of weight and sodium/potassium interventions. Prev Med. 1984 May;13(3):233-44. doi: 10.1016/0091-7435(84)90081-1.
    Results Reference
    background
    PubMed Identifier
    3881608
    Citation
    Langford HG, Blaufox MD, Oberman A, Hawkins CM, Curb JD, Cutter GR, Wassertheil-Smoller S, Pressel S, Babcock C, Abernethy JD, et al. Dietary therapy slows the return of hypertension after stopping prolonged medication. JAMA. 1985 Feb 1;253(5):657-64.
    Results Reference
    background
    PubMed Identifier
    6488753
    Citation
    Langford HG, Schlundt D, Levine K. Sodium restriction in hypertension. Compr Ther. 1984 Sep;10(9):6-11.
    Results Reference
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    Dietary Intervention Study for Hypertension (DISH)

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