NCT00000497

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enable drug controlled hypertensive patients to remain at 'goal blood pressures' after antihypertensive medication was withdrawn.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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1980

Longer than P75 for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1980

Completed
14.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

April 15, 2015

Status Verified

January 1, 2000

First QC Date

October 27, 1999

Last Update Submit

April 14, 2015

Conditions

Interventions

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    BACKGROUND
  • 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.

    PMID: 6342972BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 6494106BACKGROUND
  • 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.

    PMID: 3881608BACKGROUND
  • Langford HG, Schlundt D, Levine K. Sodium restriction in hypertension. Compr Ther. 1984 Sep;10(9):6-11.

    PMID: 6488753BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

Diet, Sodium-RestrictedDiet, Reducing

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Herbert Langford

    University of Mississippi Medical Center

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

January 1, 1980

Study Completion

September 1, 1994

Last Updated

April 15, 2015

Record last verified: 2000-01