Observational Cohort Study of Sodium, Weight and CVD - Tabular View

Tracking Information

First Received Date ^ICMJE

September 28, 2000

Last Updated Date

January 18, 2008

Start Date ^ICMJE

September 1999

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006308 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Observational Cohort Study of Sodium, Weight and CVD

Official Title ^ICMJE

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 2,182 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 2,382 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 Phase

N/A

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Cardiovascular Diseases
Heart Diseases
Hypertension

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2004

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

No eligibility criteria

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00006308

Responsible Party

Study ID Numbers ^ICMJE

916

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

Nancy Cook

Brigham and Women's Hospital

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP