Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000535
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
1999-10-27
Brief Title:
Trial of Nonpharmacologic Interventions in Elderly TONE
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 diastolicsystolic 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 15090 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
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 diastolicsystolic 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 15090 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL048641 | NIH | None | None |
| R01HL048642 | NIH | None | httpsreporternihgovquickSearchR01HL048642 |