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
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Condition or disease | Intervention/treatment |
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Cardiovascular Diseases Heart Diseases Hypertension Coronary Disease Myocardial Infarction | Drug: Chlorthalidone Drug: Lisinopril Drug: Amlodipine Drug: Doxazosin |
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.
Study Type : | Observational |
Actual Enrollment : | 37939 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pharmacological Association of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on Blood Pressure and Cardiovascular Risk in Relation to Anti-hypertensive Treatment |
Study Start Date : | September 1999 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | August 2005 |

Group/Cohort | Intervention/treatment |
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Chlorthalidone
Participants will take chlorthalidone at recommended doses to control hypertension
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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 |
Amlodipine
Participants will take Amlodipine at recommended doses to control hypertension
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Drug: Amlodipine
participant's drug dose will be titrated from 10mg to 40mg over the course of the study
Other Name: Norvasc |
Lisinopril
Participants will take Lisinopril at recommended doses to control hypertension
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Drug: Lisinopril
participant's drug dose will be titrated from 10mg to 40mg over the course of the study
Other Name: Zestoretic |
Doxazosin
Participants will take Doxazosin at recommended doses to control hypertension
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Drug: Doxazosin
participant's drug dose will be titrated from 2mg to 8mg over the course of the study
Other Name: Cardura |
- 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
- 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

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006294
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536 |
Principal Investigator: | Donna Arnett | University of Kentucky |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Donna Arnett, 257-5678, PI, University of Kentucky |
ClinicalTrials.gov Identifier: | NCT00006294 |
Other Study ID Numbers: |
911 R01HL063082 ( U.S. NIH Grant/Contract ) |
First Posted: | September 26, 2000 Key Record Dates |
Last Update Posted: | April 6, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Cardiovascular Diseases Myocardial Infarction Heart Diseases Coronary Disease Infarction Vascular Diseases Ischemia Pathologic Processes Necrosis Myocardial Ischemia Amlodipine Lisinopril Chlorthalidone Doxazosin |
Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Cardiotonic Agents Protective Agents Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors |