Trial of Nonpharmacologic Interventions in Elderly (TONE)
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|ClinicalTrials.gov Identifier: NCT00000535|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases||Behavioral: diet, reducing Behavioral: diet, sodium-restricted||Phase 3|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Factorial Assignment|
|Study Start Date :||April 1992|
|Actual Study Completion Date :||March 1997|
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
|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|
|OverallOfficial:||Walter Ettinger||Bowman Gray School of Medicine|