Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006308
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2000-09-28
Brief Title:
Observational Cohort Study of Sodium Weight and Cardiovascular Disease
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Observational Cohort Study of Sodium Weight and Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2014-05
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 investigate cardiovascular events among individuals with low sodium intake or large weight changes in a prospective observational follow-up of subjects from the Trials of Hypertension Prevention TOHP study
Detailed Description:
BACKGROUND
Sodium reduction and weight loss lead to decreased blood pressure BP Among hypertensives BP lowering leads to decreased risk of MI stroke and cardiovascular death Nonetheless concerns have been raised about increased numbers of cardiovascular events among individuals with low sodium intake or large weight changes
DESIGN NARRATIVE
The prospective observational follow-up of the Trials of Hypertension Prevention TOHP includes cardiovascular events among the 4 507 surviving participants from the ten clinical centers involved in Phases I and II of TOHP Phase I was a randomized trial of the effects of non- pharmacologic interventions including sodium reduction and weight loss on BP over 18 months of follow-up with 2182 participants Phase II examined the effects of sodium reduction and weight loss on BP over a longer 36-month period in a randomized 2X2 factorial design with 2382 participants During follow-up in Phases I and II of TOHP several measures of both weight and sodium excretion were carefully obtained on all participants The prospective observational follow-up specifically examines whether these values with an emphasis on average level of sodium excretion and weight changes are predictive of later cardiovascular disease The follow-up is conducted centrally by mail from the Division of Preventive Medicine which served as the Coordinating Center for Phases I and II and which has been very successful in conducting such large-scale studies by mail Information on cardiovascular events subsequent to the trial periods is collected through June 2003 representing an average follow-up of approximately fourteen years from the end of Phase I and eight years from the end of Phase II This cohort provides a unique resource to address the impact in a normotensive population of salt restriction and weight change on subsequent cardiovascular events
Sodium reduction and weight loss lead to decreased blood pressure BP Among hypertensives BP lowering leads to decreased risk of MI stroke and cardiovascular death Nonetheless concerns have been raised about increased numbers of cardiovascular events among individuals with low sodium intake or large weight changes
DESIGN NARRATIVE
The prospective observational follow-up of the Trials of Hypertension Prevention TOHP includes cardiovascular events among the 4 507 surviving participants from the ten clinical centers involved in Phases I and II of TOHP Phase I was a randomized trial of the effects of non- pharmacologic interventions including sodium reduction and weight loss on BP over 18 months of follow-up with 2182 participants Phase II examined the effects of sodium reduction and weight loss on BP over a longer 36-month period in a randomized 2X2 factorial design with 2382 participants During follow-up in Phases I and II of TOHP several measures of both weight and sodium excretion were carefully obtained on all participants The prospective observational follow-up specifically examines whether these values with an emphasis on average level of sodium excretion and weight changes are predictive of later cardiovascular disease The follow-up is conducted centrally by mail from the Division of Preventive Medicine which served as the Coordinating Center for Phases I and II and which has been very successful in conducting such large-scale studies by mail Information on cardiovascular events subsequent to the trial periods is collected through June 2003 representing an average follow-up of approximately fourteen years from the end of Phase I and eight years from the end of Phase II This cohort provides a unique resource to address the impact in a normotensive population of salt restriction and weight change on subsequent cardiovascular events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL057915 | NIH | None | httpsreporternihgovquickSearchR01HL057915 |