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Trial of Nonpharmacologic Interventions in Elderly (TONE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000535
First Posted: October 28, 1999
Last Update Posted: November 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To test the efficacy of weight loss and sodium restriction, alone and combined, in maintaining the normotensive state following withdrawal of antihypertensive medications in an elderly cohort. Conducted in collaboration with the National Institute on Aging.

Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Behavioral: diet, reducing Behavioral: diet, sodium-restricted Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1992
Study Completion Date: March 1997
Detailed Description:

BACKGROUND:

An estimated 30 to 40 percent of elderly persons are treated with blood pressure medications. The efficacy of blood pressure drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven, but such therapy can adversely affect quality of life and biochemical profile. In 1992 when the study started, there was a compelling rationale to identify what proportion of medicated, well-controlled elderly hypertensives could be maintained long-term or greater than 30 months in the normotensive state following withdrawal of blood pressure medications. There was also a need to determine whether nonpharmacologic therapy could significantly increase the proportion with a successful outcome.

DESIGN NARRATIVE:

Randomized. A total of 585 overweight subjects were assigned in a 2 x 2 factorial design to weight loss, sodium reduction, combined weight loss and sodium reduction, or usual life-style control. The remaining 390 subjects of normal weight were assigned in a 2-armed design to a sodium reduction or an attention control group. The control groups were engaged in a series of non-blood pressure related health encounters designed to control for non-specific effects of groups contacts. Withdrawal of antihypertensive medication was attempted following three months of intervention. The primary endpoint was a blood pressure of 150/90 mm Hg or greater, resumption of antihypertensive drug therapy, or the occurrence of a blood pressure-related clinical complication during two to three years of follow-up. Recruitment ended in June, 1994. Follow-up ended in December, 1995. NHLBI support for the trial ended in March, 1997. The NIA supported the Coordinating Center and two clinical centers through February 1998.

The study completion date listed in this record was obtained from the "Completed Date" entered from the old format in the Protocol Registration and Results System (PRS).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women with a systolic blood pressure of less than 145 mm Hg and diastolic blood pressure of less than 85 mm Hg on single-drug therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000535


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
United States, North Carolina
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
Investigators
OverallOfficial: Walter Ettinger Bowman Gray School of Medicine
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000535     History of Changes
Other Study ID Numbers: 78
R01HL048641 ( U.S. NIH Grant/Contract )
R01HL048642 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: November 7, 2016
Last Verified: October 2002

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Vascular Diseases