Control of Hypertension by Non-Pharmacologic Means

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000498
• Other study ID #: 17
• Secondary ID: R01HL024999
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: July 25, 2016
• Start date: April 1980
• Est. completion date: March 1983

Study information

• Verified date: January 2000
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 1983
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 100 Years
• Eligibility: Men and women with controlled hypertension.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Vascular Diseases

Intervention

Behavioral:
• diet, sodium-restricted

• diet, reducing

• alcohol restriction

Drug:
• antihypertensive agents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation