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Observational Cohort Study of Sodium, Weight and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT00006308
Recruitment Status : Completed
First Posted : September 29, 2000
Last Update Posted : May 8, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nancy Cook, ScD, Brigham and Women's Hospital

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.

Condition or disease
Cardiovascular Diseases Heart Diseases Hypertension

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 Type : Observational
Official Title: Observational Cohort Study of Sodium, Weight and Cardiovascular Disease
Study Start Date : September 1999
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006308


Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nancy R Cook, ScD Brigham and Women's Hospital

Responsible Party: Nancy Cook, ScD, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00006308     History of Changes
Other Study ID Numbers: 916
R01HL057915 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2000    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases