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
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Men and women with controlled hypertension.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000498
First Posted
October 27, 1999
Last Updated
July 25, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
Learn more about this trial
Control of Hypertension by Non-Pharmacologic Means
We'll reach out to this number within 24 hrs