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Analyzing How Genetics May Affect Response to High Blood Pressure Medications

This study has been completed.
Sponsor:
Collaborators:
University of Texas
University of Minnesota - Clinical and Translational Science Institute
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00563901
First received: November 21, 2007
Last updated: March 2, 2014
Last verified: January 2008

November 21, 2007
March 2, 2014
September 2000
May 2004   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00563901 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Analyzing How Genetics May Affect Response to High Blood Pressure Medications
GenHAT - Genetics of Hypertension Associated Treatments - Ancillary to ALLHAT

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples with DNA

Non-Probability Sample

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.

  • Hypertension
  • Coronary Disease
  • Cerebrovascular Accident
Not Provided
1
Adults with a high risk for high blood pressure from the ALLHAT study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37939
May 2004
May 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant in the ALLHAT study
Both
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00563901
1402, R01HL063082-07A1, R01 HL063082-07A1
Not Provided
Donna K. Arnett, PhD, University of Alabama at Birmingham
University of Alabama at Birmingham
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Texas
  • University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Donna K. Arnett, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP