Biochemical and Genetic Markers of Hypertension in Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Howard D. Sesso, ScD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00090467
First received: August 26, 2004
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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


Condition
Cardiovascular Diseases
Hypertension
Heart Diseases
Inflammation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incident hypertension [ Time Frame: Median follow-up of 5.9 years ] [ Designated as safety issue: No ]

Enrollment: 1600
Study Start Date: August 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Hypertension affects up to 50 million Americans, and is a major risk factor for cardiovascular disease and other health outcomes. Among Black women, hypertension is more prevalent, less well controlled by treatment, and has more damaging health outcomes versus Whites for reasons still unclear. While several lifestyle and dietary factors are associated with hypertension, relevant biochemical and genetic markers remain less well studied

DESIGN NARRATIVE:

This is a nested case-control study of incident hypertension in 800 case-control pairs (400 each of white and black women, totaling 1,600 women). Data will be used from the Women's Health Initiative Observational Study (WHI-OS), a cohort of 93,676 ethnically diverse postmenopausal women aged 50 to 79 years with extensive clinical and questionnaire data. Three hypotheses will be tested. First, the investigators will assess whether markers of inflammation - C reactive protein (CRP), interleukin-6 (IL-6), IL-1-8, tumor necrosis factor (TNF) receptor 2, soluble intercellular adhesion molecule-1 (slCAM-1), and metalloproteinase-9 (MMP-9) - are associated with the risk of hypertension in White and Black women. Second, they will examine six novel polymorphisms linked to the above inflammatory biomarkers - the CRP, IL-6, IL-1-beta, TNF-a, slCAM-1, and MMP-9 genes- and two other polymorphisms related to inflammation and the metabolic syndrome- the adiponectin and PPAR-y2 genes - for their potentially important associations with the risk of hypertension. Third, they will comprehensively evaluate important single-nucleotide polymorphisms in the above genes and examine associations between common haplotypes and hypertension risk in White and Black women, using state-of-the art genotyping technology and statistical methods. Power is excellent; for each biochemical marker, they have 80% power to detect a trend across quintiles for a relative risk (RR) of hypertension, comparing the fifth versus first quintiles, of 1.49 for analyses of 800 case-control pairs and 1.74 for analyses of 400 case-control pairs. For each genetic marker, they have 80% power to detect an additive effect of an allele for a RR of hypertension of 1.36 for 800 case-control pairs and 1.57 for 400 case-control pairs.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women's Health Initiative Observational Study (WHI OS)

Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00090467

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Howard D Sesso, ScD, MPH Brigham & Women"s Hospital
  More Information

No publications provided

Responsible Party: Howard D. Sesso, ScD, MPH, Associate Epidemiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00090467     History of Changes
Other Study ID Numbers: 1267, R01HL075455-01
Study First Received: August 26, 2004
Last Updated: July 26, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Inflammation
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014