Trial of Nonpharmacologic Interventions in Elderly (TONE)

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000535
• Other study ID #: 78
• Secondary ID: R01HL048641R01HL
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: November 4, 2016
• Start date: April 1992
• Est. completion date: March 1997

Study information

• Verified date: October 2002
• 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Vascular Diseases

Intervention

Behavioral:
• diet, reducing

• diet, sodium-restricted

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Tennessee	Memphis	Tennessee
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Bowman Gray School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (9)

Appel LJ, Espeland M, Whelton PK, Dolecek T, Kumanyika S, Applegate WB, Ettinger WH Jr, Kostis JB, Wilson AC, Lacy C, et al. Trial of Nonpharmacologic Intervention in the Elderly (TONE). Design and rationale of a blood pressure control trial. Ann Epidemiol. 1995 Mar;5(2):119-29. — View Citation

Appel LJ, Espeland MA, Easter L, Wilson AC, Folmar S, Lacy CR. Effects of reduced sodium intake on hypertension control in older individuals: results from the Trial of Nonpharmacologic Interventions in the Elderly (TONE). Arch Intern Med. 2001 Mar 12;161(5):685-93. — View Citation

Espeland MA, Kumanyika S, Kostis JB, Algire J, Applegate WB, Ettinger W, Whelton PK, Bahnson J. Antihypertensive medication use among recruits for the Trial of Nonpharmacologic Interventions in the Elderly (TONE). J Am Geriatr Soc. 1996 Oct;44(10):1183-9. — View Citation

Kostis JB, Espeland MA, Appel L, Johnson KC, Pierce J, Wofford JL. Does withdrawal of antihypertensive medication increase the risk of cardiovascular events? Trial of Nonpharmacologic Interventions in the Elderly (TONE) Cooperative Research Group. Am J Cardiol. 1998 Dec 15;82(12):1501-8. — View Citation

Kostis JB, Wilson AC, Hooper WC, Harrison KW, Philipp CS, Appel LJ, Espeland MA, Folmar S, Johnson KC; TONE Cooperative Research Group. Trial Of Nonpharmacologic interventions in the Elderly.. Association of angiotensin-converting enzyme DD genotype with blood pressure sensitivity to weight loss. Am Heart J. 2002 Oct;144(4):625-9. — View Citation

Kostis JB, Wilson AC, Shindler DM, Cosgrove NM, Lacy CR. Persistence of normotension after discontinuation of lifestyle intervention in the trial of TONE. Trial of Nonpharmacologic Interventions in the Elderly. Am J Hypertens. 2002 Aug;15(8):732-4. — View Citation

Kumanyika SK, Espeland MA, Bahnson JL, Bottom JB, Charleston JB, Folmar S, Wilson AC, Whelton PK; TONE Cooperative Research Group.. Ethnic comparison of weight loss in the Trial of Nonpharmacologic Interventions in the Elderly. Obes Res. 2002 Feb;10(2):96-106. — View Citation

Whelton PK, Appel LJ, Espeland MA, Applegate WB, Ettinger WH Jr, Kostis JB, Kumanyika S, Lacy CR, Johnson KC, Folmar S, Cutler JA. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group. JAMA. 1998 Mar 18;279(11):839-46. Erratum in: JAMA 1998 Jun 24;279(24):1954. — View Citation

Whelton PK, Babnson J, Appel LJ, Charleston J, Cosgrove N, Espeland MA, Folmar S, Hoagland D, Krieger S, Lacy C, Lichtermann L, Oates-Williams F, Tayback M, Wilson AC. Recruitment in the Trial of Nonpharmacologic Intervention in the Elderly (TONE). J Am Geriatr Soc. 1997 Feb;45(2):185-93. — View Citation