Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1980-04-30
1983-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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diet, sodium-restricted
diet, reducing
alcohol restriction
antihypertensive agents
Eligibility Criteria
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Inclusion Criteria
40 Years
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Principal Investigators
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Richard Grimm
Role:
MOUNT SINAI HOSPITAL
Jeremiah Stamler
Role:
Northwestern University
References
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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.
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.
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.
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.
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.
Other Identifiers
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17
Identifier Type: -
Identifier Source: org_study_id
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