Observational Cohort Study of Sodium, Weight and Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy Cook, ScD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00006308
First received: September 28, 2000
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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
Cardiovascular Diseases
Heart Diseases
Hypertension

Study Type: Observational
Official Title: Observational Cohort Study of Sodium, Weight and Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Study Start Date: September 1999
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006308

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Nancy R Cook, ScD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Nancy Cook, ScD, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00006308     History of Changes
Other Study ID Numbers: 916, R01HL057915
Study First Received: September 28, 2000
Last Updated: May 7, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014