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Completed

NCT Number: NCT00006294

Genetics of Hypertension Associated Treatments (GenHAT)

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.

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Key information

Conditions

Cardiovascular Diseases Coronary Disease Heart Diseases Hypertension Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Chlorthalidone

Drug

participant's drug dose will be titrated from 12.5mg to 25mg over the course of the study

Other names: Hygroton, Thalitone, Chlorthalid

Lisinopril

Drug

participant's drug dose will be titrated from 10mg to 40mg over the course of the study

Other names: Zestoretic

Amlodipine

Drug

participant's drug dose will be titrated from 10mg to 40mg over the course of the study

Other names: Norvasc

Doxazosin

Drug

participant's drug dose will be titrated from 2mg to 8mg over the course of the study

Other names: Cardura

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Donna Arnett, 257-5678

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Minnesota

Registry information

Official study title

Pharmacological Association of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on Blood Pressure and Cardiovascular Risk in Relation to Anti-hypertensive Treatment

Acronym: GenHAT

Important dates

Study start
1999
Primary completion
2005
Study completion
2005
First posted
Sep 26, 2000
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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