NCT00090467

Brief Summary

To investigate biochemical and genetic markers of inflammation and endothelial dysfunction as determinants of hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

3.9 years

First QC Date

August 26, 2004

Last Update Submit

July 26, 2013

Conditions

Cardiovascular DiseasesHypertensionHeart DiseasesInflammation

Outcome Measures

Primary Outcomes (1)

  • Incident hypertension

    Median follow-up of 5.9 years

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women's Health Initiative Observational Study (WHI OS)

We included White and Black WHI-OS participants aged \<70 years, and excluded women with any baseline history of hypertension (via self-report, measured BP, or medication use), non-melanoma cancer, myocardial infarction, revascularization procedures, congestive heart failure, angina pectoris, or stroke. Further, women developing myocardial infarction or stroke, or dying from coronary heart disease or stroke during follow-up were excluded. Only for potential hypertension cases, women with revascularization procedures, congestive heart failure, angina pectoris, or non-melanoma cancer prior to or \<30 days after the diagnosis of hypertension were also excluded. Finally, we excluded women with inadequate bloods or who refused to participate in a genetic study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionHeart DiseasesInflammation

Condition Hierarchy (Ancestors)

Vascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Howard D Sesso, ScD, MPH

    Brigham & Women"s Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Epidemiologist

Study Record Dates

First Submitted

August 26, 2004

First Posted

August 30, 2004

Study Start

August 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 30, 2013

Record last verified: 2013-07