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Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs

This study is currently recruiting participants.
Verified January 2012 by University of Washington
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bruce Psaty, University of Washington
ClinicalTrials.gov Identifier:
NCT00573092
First received: December 12, 2007
Last updated: January 4, 2012
Last verified: January 2012
History of Changes

December 12, 2007
January 4, 2012
September 2007
July 2012   (final data collection date for primary outcome measure)
Genomic regions for each of the four major drug classes that influence drug and gene interaction [ Time Frame: Measured at completion of genetic analysis ] [ Designated as safety issue: No ]
Genomic regions for each of the 4 major drug classes that influence drug and gene interaction [ Time Frame: Measured at completion of genetic analysis ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00573092 on ClinicalTrials.gov Archive Site
Ethnic-specific genetic variations for each of the four major drug classes that influence drug and gene interaction [ Time Frame: Measured at completion of genetic analysis ] [ Designated as safety issue: No ]
Ethinic-specific genetic variations for each of the 4 major drug classes that influence drug and gene interaction [ Time Frame: Measured at completion of genetic analysis ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs
Genome-Wide Case-Only Study of Antihypertensive Drug-Gene Interactions

High blood pressure is one of the most common health problems in the United States. There are many drug treatment options for high blood pressure, but these medications are not always effective. People with treated high blood pressure can still suffer from other serious cardiovascular health problems, including heart attack, sudden death, or stroke. Genetic variations may cause some people to be more susceptible to these cardiovascular outcomes despite treatment. This study will identify new gene regions that may influence the effectiveness of high blood pressure drugs in preventing the above mentioned cardiovascular conditions.

High blood pressure affects nearly one in three individuals in the United 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 stroke, heart attack, and heart failure. There are four major classes of drugs used to treat high blood pressure, which include diuretics, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and calcium antagonists. Each class works differently in treating high blood pressure, and certain gene regions may affect the effectiveness of the various high blood pressure drugs. The purpose of this study is to identify new gene regions that may influence the effectiveness of the four major high blood pressure drug types in preventing a heart attack, sudden death, or stroke.

This study will draw upon specimens and data from three large population-based studies: the Group Health population, the Cardiovascular Heart Study, and the Jackson Heart Study. New samples of DNA and laboratory data will only be collected from participants in the Group Health population. The remaining samples will be pre-existing samples from the other two studies. Through a whole-genome study of the DNA samples, researchers will distinguish genomic regions of interest for the four major drug classes to identify associations between the drugs and genes in the population. Researchers will further genotype the "interesting" genomic regions discovered in the whole-genome study. Ethnic-specific genetic variations will also be identified to fully characterize the genetic variations. The study will be replicated to assess the validity of the findings.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Previously collected and new samples with DNA
Non-Probability Sample

Data and specimens for this study will be collected from three population-based studies: Group Health population, Cardiovascular Heart Study, and Jackson Heart Study. The Group Health population will provide new DNA samples; the Cardiovascular Heart and Jackson Heart studies will provide existing DNA specimens to replicate the study findings from the Group Health population. The Cardiovascular Heart Study involves Americans over the age of 65. The Jackson Heart Study is a cardiovascular disease study in African Americans.
  • Myocardial Infarction
  • Cerebrovascular Accident
  • Death, Sudden, Cardiac
Not Provided
1
Data and specimens from three large population-based studies of heart attack, sudden death, and stroke in people treated for high blood pressure with one of the four major classes of high blood pressure drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7900
September 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Experience of a first heart attack, stroke, or sudden death
  • Member of the Group Health Center (GHC) treated for high blood pressure
  • Enrolled at least 1 year in one of the three study populations
  • Treated for high blood pressure with one of the four major classes of high blood pressure drugs (diuretics, beta-blockers, ACE inhibitors, or calcium antagonists)
Both
30 Years to 79 Years
No
Contact: Nicole L. Glazer, PhD, MPH 206-287-2777 nlg@u.washington.edu
United States
 
NCT00573092
1411, R01HL085251-01A1, R01 HL085251-01A1
No
Bruce Psaty, University of Washington
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bruce M. Psaty, MD, PhD University of Washington
University of Washington
January 2012

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