Genetics of Hypertension Associated Treatments (GenHAT)
NCT ID: NCT00006294
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
37939 participants
OBSERVATIONAL
1999-09-30
2005-08-31
Brief Summary
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Detailed Description
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The study might shed important light on the variation in patient response to antihypertensive agents, and improve the ability to pick the right antihypertensive for specific patients. GenHAT is an ancillary study to ALLHAT (the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). ALLHAT recruited 42,515 hypertensives and randomized them to one of four antihypertensive agents (lisinopril, chlorthalidone, amlodipine, and doxazosin); follow-up will be completed in March, 2002.
DESIGN NARRATIVE:
GenHAT, a prospective study ancillary to ALLHAT, will characterize hypertension genetic variants and determine their interaction with antihypertensive treatments in relation to coronary heart disease (CHD). DNA from frozen clots stored at the ALLHAT Central Laboratory will be used to genotype variants of hypertension genes (angiotensinogen -6, angiotensin converting enzyme insertion/deletion, angiotensin type- 1 receptor, alpha-adducin, beta2 adrenergic receptor, lipoprotein lipase, and 10 new hypertension variants expected to be discovered during the course of the study). In addition to the primary aim, a number of secondary aims will be undertaken to evaluate gene- treatment interactions in relation to other endpoints, including all-cause mortality, stroke, heart failure, left ventricular hypertrophy, decreased renal function, peripheral arterial disease, and blood pressure lowering. Because of the ethnic and gender diversity of ALLHAT, an assessment will be made of the effects of these variants on outcomes in key subgroups (age \>65 years, women, African Americans, Type II diabetics), and whether the gene-treatment interactions in relation to outcomes are consistent across subgroups.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chlorthalidone
Participants will take chlorthalidone at recommended doses to control hypertension
Chlorthalidone
participant's drug dose will be titrated from 12.5mg to 25mg over the course of the study
Amlodipine
Participants will take Amlodipine at recommended doses to control hypertension
Amlodipine
participant's drug dose will be titrated from 10mg to 40mg over the course of the study
Lisinopril
Participants will take Lisinopril at recommended doses to control hypertension
Lisinopril
participant's drug dose will be titrated from 10mg to 40mg over the course of the study
Doxazosin
Participants will take Doxazosin at recommended doses to control hypertension
Doxazosin
participant's drug dose will be titrated from 2mg to 8mg over the course of the study
Interventions
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Chlorthalidone
participant's drug dose will be titrated from 12.5mg to 25mg over the course of the study
Lisinopril
participant's drug dose will be titrated from 10mg to 40mg over the course of the study
Amlodipine
participant's drug dose will be titrated from 10mg to 40mg over the course of the study
Doxazosin
participant's drug dose will be titrated from 2mg to 8mg over the course of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* use of anti-hypertensives for less than two months with a baseline blood pressure between 140/90 and 180/110
* use of anti-hypertensives for greater than two months with a blood pressure not greater than 160/100
* at least one additional cardiovascular risk factor such as previous MI, stroke, type 2 diabetes, smoking, left ventricular hypertrophy or dyslipidemia
55 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Donna Arnett, 257-5678
OTHER
Responsible Party
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Donna Arnett, 257-5678
PI
Principal Investigators
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Donna Arnett
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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References
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Arnett DK, Boerwinkle E, Davis BR, Eckfeldt J, Ford CE, Black H. Pharmacogenetic approaches to hypertension therapy: design and rationale for the Genetics of Hypertension Associated Treatment (GenHAT) study. Pharmacogenomics J. 2002;2(5):309-17. doi: 10.1038/sj.tpj.6500113.
Arnett DK, Davis BR, Ford CE, Boerwinkle E, Leiendecker-Foster C, Miller MB, Black H, Eckfeldt JH. Pharmacogenetic association of the angiotensin-converting enzyme insertion/deletion polymorphism on blood pressure and cardiovascular risk in relation to antihypertensive treatment: the Genetics of Hypertension-Associated Treatment (GenHAT) study. Circulation. 2005 Jun 28;111(25):3374-83. doi: 10.1161/CIRCULATIONAHA.104.504639. Epub 2005 Jun 20.
Zhang X, Lynch AI, Davis BR, Ford CE, Boerwinkle E, Eckfeldt JH, Leiendecker-Foster C, Arnett DK. Pharmacogenetic association of NOS3 variants with cardiovascular disease in patients with hypertension: the GenHAT study. PLoS One. 2012;7(3):e34217. doi: 10.1371/journal.pone.0034217. Epub 2012 Mar 28.
Other Identifiers
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911
Identifier Type: -
Identifier Source: org_study_id
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