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Genetics of Hypertension Associated Treatments (GenHAT) (GenHAT)

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ClinicalTrials.gov Identifier: NCT00006294
Recruitment Status : Completed
First Posted : September 26, 2000
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Donna Arnett, 257-5678, University of Kentucky

September 25, 2000
September 26, 2000
April 6, 2018
September 1999
August 2005   (Final data collection date for primary outcome measure)
Blood Pressure [ Time Frame: baseline and six month ]
Blood pressure will be measured to determine the effect of the prescribed anti-hypertensive . Data will be presented as the change in blood pressure over the course of six months
Not Provided
Complete list of historical versions of study NCT00006294 on ClinicalTrials.gov Archive Site
Effect of genotype on event rates [ Time Frame: 6 years ]
The rate of fatal myocardial infarction (MI) was evaluated in relation to the ACE I/D genotype and anti-hypertensive used. Data are presented as the incidence of fatal MI after six years of follow up
Not Provided
Not Provided
Not Provided
 
Genetics of Hypertension Associated Treatments (GenHAT)
Pharmacological Association of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on Blood Pressure and Cardiovascular Risk in Relation to Anti-hypertensive Treatment
To examine whether the association between selected hypertensive genes and combined fatal coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is modified by the type of antihypertensive treatment, leading to differential risks of coronary heart disease.

BACKGROUND:

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Hypertensive individuals, multiple races and ethnic groups are represented in this study population
  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
  • Coronary Disease
  • Myocardial Infarction
  • Drug: Chlorthalidone
    participant's drug dose will be titrated from 12.5mg to 25mg over the course of the study
    Other Name: Hygroton, Thalitone, Chlorthalid
  • Drug: Lisinopril
    participant's drug dose will be titrated from 10mg to 40mg over the course of the study
    Other Name: Zestoretic
  • Drug: Amlodipine
    participant's drug dose will be titrated from 10mg to 40mg over the course of the study
    Other Name: Norvasc
  • Drug: Doxazosin
    participant's drug dose will be titrated from 2mg to 8mg over the course of the study
    Other Name: Cardura
  • Chlorthalidone
    Participants will take chlorthalidone at recommended doses to control hypertension
    Intervention: Drug: Chlorthalidone
  • Amlodipine
    Participants will take Amlodipine at recommended doses to control hypertension
    Intervention: Drug: Amlodipine
  • Lisinopril
    Participants will take Lisinopril at recommended doses to control hypertension
    Intervention: Drug: Lisinopril
  • Doxazosin
    Participants will take Doxazosin at recommended doses to control hypertension
    Intervention: Drug: Doxazosin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37939
Not Provided
August 2005
August 2005   (Final data collection date for primary outcome measure)
  • not taking anti-hypertensive medication
  • 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
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00006294
911
R01HL063082 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Donna Arnett, 257-5678, University of Kentucky
Donna Arnett, 257-5678
  • University of Minnesota - Clinical and Translational Science Institute
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Donna Arnett University of Kentucky
University of Kentucky
April 2018