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Genetics of Hypertension Associated Treatments (GenHAT)

D

Donna Arnett, 257-5678

Status

Completed

Conditions

Hypertension
Myocardial Infarction
Cardiovascular Diseases
Coronary Disease
Heart Diseases

Treatments

Drug: Chlorthalidone
Drug: Lisinopril
Drug: Amlodipine
Drug: Doxazosin

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00006294
R01HL063082 (U.S. NIH Grant/Contract)
911

Details and patient eligibility

About

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.

Full description

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.

Enrollment

37,939 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • 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

Trial design

37,939 participants in 4 patient groups

Chlorthalidone
Description:
Participants will take chlorthalidone at recommended doses to control hypertension
Treatment:
Drug: Chlorthalidone
Amlodipine
Description:
Participants will take Amlodipine at recommended doses to control hypertension
Treatment:
Drug: Amlodipine
Lisinopril
Description:
Participants will take Lisinopril at recommended doses to control hypertension
Treatment:
Drug: Lisinopril
Doxazosin
Description:
Participants will take Doxazosin at recommended doses to control hypertension
Treatment:
Drug: Doxazosin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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