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CompletedNCT00563901Updated Mar 4, 2014

Analyzing How Genetics May Affect Response to High Blood Pressure Medications

An observational study in Hypertension, Coronary Disease and Cerebrovascular Accident, sponsored by University of Alabama at Birmingham. Completed at 2 sites in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-04.

Sponsored by University of Alabama at Birmingham · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
37,939
Ages
55 Years and older
Sex
All
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Study summary

High blood pressure is one of the most common health problems in the United States. There are many medications to treat high blood pressure, but there is a large variance in how people respond to these medications. It is believed that genetic variations may contribute to the inconsistent treatment response. This study will use genetic analysis to determine whether particular genes interact with high blood pressure medications to modify the risk of certain cardiovascular diseases.

Read the detailed description

High blood pressure affects nearly one in three individuals in the Unites States. There are many factors that can cause high blood pressure, including family history and genetic traits, kidney disease, stress, diabetes, and diet. If left untreated, high blood pressure can increase one's risk for coronary heart disease (CHD), stroke, heart attack, and heart failure. While high blood pressure can be managed with medication, people receiving medication treatment for high blood pressure are still variably at risk for CHD and other cardiovascular conditions. This risk variation may stem from varying drug reactions that are likely due to genetics. This study will use genetic analysis to determine whether particular genes interact with high blood pressure medications to modify the risk of certain cardiovascular diseases.

This is a continuation study to the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT), which included a randomized trial of the four high blood pressure drugs chlorthalidone, amlodipine, lisinopril, and doxazosin. Using samples from ALLHAT participants, this study will analyze the interactions of candidate gene pathways of relevance with medications from the ALLHAT study. Researchers will examine both single DNA building blocks and multiple genes in the candidate gene pathways and determine whether their interaction with the ALLHAT drugs modifies the risk of cardiovascular outcomes. Researchers will perform genetic analysis on 96 genetic markers using structured association testing (SAT) and false discovery rate (FDR) methods. These methods will control for population stratification and multiple testing. Finally, the study will establish a mechanism for other researchers to continue further analysis of the genetic variants examined in this study.

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Conditions studied

  • Hypertension
  • Coronary Disease
  • Cerebrovascular Accident

Keywords

  • CHD
  • Combined CHD
  • Stroke
  • Combined Cardiovascular Disease (CVD)
  • Pharmacogenetics
  • End-Stage Renal Disease
  • Heart Failure
  • Hospitalized/Fatal Heart Failure
  • Angina
  • Coronary Revascularizations
  • CHD Mortality
  • Lisinopril
  • Chlorthalidone
  • Amlodipine
  • Doxazosin
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 37,939 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population samples will be taken from adults who are high risk for high blood pressure in the ALLHAT study, which included a randomized trial of the four high blood pressure drugs chlorthalidone, amlodipine, lisinopril, and doxazosin.

Eligibility criteria

Inclusion Criteria:

  • Participant in the ALLHAT study
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
37,939 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Adults with a high risk for high blood pressure from the ALLHAT study

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What researchers measure

Primary outcomes

  1. Candidate genes that interact with ALLHAT high blood pressure medications to modify risk of other cardiovascular conditions

    Time frame: Measured at completion of genetic analysis

Secondary outcomes

  1. Within selected candidate genes, effect of multiple gene interactions with high blood pressure medications in modifying risk of other cardiovascular conditions

    Time frame: Measured at completion of genetic analysis

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Study locations

2 sites
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • University of Texas Houston
    Houston, Texas 77030, United States
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References and documents

Publications

  • 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. PubMed 12439737 ↗
  • Davis BR, Ford CE, Boerwinkle E, Arnett D, Eckfeldt J, Black H. Imputing gene-treatment interactions when the genotype distribution is unknown using case-only and putative placebo analyses--a new method for the Genetics of Hypertension Associated Treatment (GenHAT) study. Stat Med. 2004 Aug 15;23(15):2413-27. doi: 10.1002/sim.1831. PubMed 15273956 ↗
  • 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. PubMed 15967849 ↗
  • Davis BR, Arnett DK, Boerwinkle E, Ford CE, Leiendecker-Foster C, Miller MB, Black H, Eckfeldt JH. Antihypertensive therapy, the alpha-adducin polymorphism, and cardiovascular disease in high-risk hypertensive persons: the Genetics of Hypertension-Associated Treatment Study. Pharmacogenomics J. 2007 Apr;7(2):112-22. doi: 10.1038/sj.tpj.6500395. Epub 2006 May 16. PubMed 16702981 ↗
  • Maitland-van der Zee AH, Boerwinkle E, Arnett DK, Davis BR, Leiendecker-Foster C, Miller MB, Klungel OH, Ford CE, Eckfeldt JH. Absence of an interaction between the angiotensin-converting enzyme insertion-deletion polymorphism and pravastatin on cardiovascular disease in high-risk hypertensive patients: the Genetics of Hypertension-Associated Treatment (GenHAT) study. Am Heart J. 2007 Jan;153(1):54-8. doi: 10.1016/j.ahj.2006.10.019. PubMed 17174637 ↗
  • Sherva R, Ford CE, Eckfeldt JH, Davis BR, Boerwinkle E, Arnett DK. Pharmacogenetic effect of the stromelysin (MMP3) polymorphism on stroke risk in relation to antihypertensive treatment: the genetics of hypertension associated treatment study. Stroke. 2011 Feb;42(2):330-5. doi: 10.1161/STROKEAHA.110.593798. Epub 2010 Dec 23. PubMed 21183746 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00563901
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Texas, University of Minnesota
First posted
Nov 26, 2007
Start date
Sep 2000
Primary completion
May 2004
Completion
May 2004
Last update
Mar 4, 2014

Study contacts

Donna K. Arnett, PhD
principal investigator · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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