Completed

Phase 3
Age: 60Years - 80Years
All Genders
ID00000535

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2016-11-07

N/A

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trial of Nonpharmacologic Interventions in Elderly (TONE)

Who Can Participate

Age: 60Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 4 locations

1

Johns Hopkins University

Baltimore, Maryland, United States

Status Unknown

2

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Status Unknown

3

Bowman Gray School of Medicine

Winston-Salem, North Carolina, United States

Status Unknown

4

University of Tennessee

Memphis, Tennessee, United States

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Antihypertensive medication use among recruits for the Trial of Nonpharmacologic Interventions in the Elderly (TONE).

M A Espeland, S Kumanyika, J B Kostis...

https://pubmed.ncbi.nlm.nih.gov/8855996

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.

P K Whelton, L J Appel, M A Espeland...

https://pubmed.ncbi.nlm.nih.gov/9515998

Does withdrawal of antihypertensive medication increase the risk of cardiovascular events? Trial of Nonpharmacologic Interventions in the Elderly (TONE) Cooperative Research Group.

J B Kostis, M A Espeland, L Appel...

https://pubmed.ncbi.nlm.nih.gov/9874055

Persistence of normotension after discontinuation of lifestyle intervention in the trial of TONE. Trial of Nonpharmacologic Interventions in the Elderly.

John B Kostis, Alan C Wilson, Daniel M Shindler...

https://pubmed.ncbi.nlm.nih.gov/12160197

Effects of reduced sodium intake on hypertension control in older individuals: results from the Trial of Nonpharmacologic Interventions in the Elderly (TONE).

L J Appel, M A Espeland, L Easter...

https://pubmed.ncbi.nlm.nih.gov/11231700

Effects of Antihypertensive Deprescribing Strategies on Blood Pressure, Adverse Events, and Orthostatic Symptoms in Older Adults: Results From TONE.

Stephen P Juraschek, Jennifer L Cluett, Matthew J Belanger...

https://pubmed.ncbi.nlm.nih.gov/34718403