Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090467
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2004-08-26
Brief Title:
Biochemical and Genetic Markers of Hypertension in Women
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate biochemical and genetic markers of inflammation and endothelial dysfunction as determinants of hypertension
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 1600 women Data will be used from the Womens Health Initiative Observational Study WHI-OS a cohort of 93676 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 149 for analyses of 800 case-control pairs and 174 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 136 for 800 case-control pairs and 157 for 400 case-control pairs
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 1600 women Data will be used from the Womens Health Initiative Observational Study WHI-OS a cohort of 93676 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 149 for analyses of 800 case-control pairs and 174 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 136 for 800 case-control pairs and 157 for 400 case-control pairs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL075455-01 | NIH | None | httpsreporternihgovquickSearchR01HL075455-01 |