NCT00006294

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,939

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

5.9 years

First QC Date

September 25, 2000

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    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

    baseline and six month

Secondary Outcomes (1)

  • Effect of genotype on event rates

    6 years

Study Arms (4)

Chlorthalidone

Participants will take chlorthalidone at recommended doses to control hypertension

Drug: Chlorthalidone

Amlodipine

Participants will take Amlodipine at recommended doses to control hypertension

Drug: Amlodipine

Lisinopril

Participants will take Lisinopril at recommended doses to control hypertension

Drug: Lisinopril

Doxazosin

Participants will take Doxazosin at recommended doses to control hypertension

Drug: Doxazosin

Interventions

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

Also known as: Hygroton, Thalitone, Chlorthalid
Chlorthalidone

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

Also known as: Zestoretic
Lisinopril

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

Also known as: Norvasc
Amlodipine

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

Also known as: Cardura
Doxazosin

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hypertensive individuals, multiple races and ethnic groups are represented in this study population

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (3)

  • 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.

    PMID: 12439737BACKGROUND
  • 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.

    PMID: 15967849BACKGROUND
  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionCoronary DiseaseMyocardial Infarction

Interventions

ChlorthalidoneLisinoprilhydrochlorothiazide, lisinopril drug combinationAmlodipineDoxazosin

Condition Hierarchy (Ancestors)

Vascular DiseasesMyocardial IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingPrazosinQuinazolines

Study Officials

  • Donna Arnett

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 25, 2000

First Posted

September 26, 2000

Study Start

September 1, 1999

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations