Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs
Primary Purpose
Myocardial Infarction, Cerebrovascular Accident, Death, Sudden, Cardiac
Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Myocardial Infarction focused on measuring Cardiovascular Epidemiology, Genomics, Genome-Wide Association Study
Eligibility Criteria
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)
Sites / Locations
- Cardiovascular Health Research Unit
Arms of the Study
Arm 1
Arm Type
Arm Label
1
Arm Description
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
Outcomes
Primary Outcome Measures
Genomic regions for each of the four major drug classes that influence drug and gene interaction
Secondary Outcome Measures
Ethnic-specific genetic variations for each of the four major drug classes that influence drug and gene interaction
Full Information
NCT ID
NCT00573092
First Posted
December 12, 2007
Last Updated
November 7, 2016
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00573092
Brief Title
Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs
Official Title
Genome-Wide Case-Only Study of Antihypertensive Drug-Gene Interactions
Study Type
Observational
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Cerebrovascular Accident, Death, Sudden, Cardiac
Keywords
Cardiovascular Epidemiology, Genomics, Genome-Wide Association Study
7. Study Design
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Description
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
Primary Outcome Measure Information:
Title
Genomic regions for each of the four major drug classes that influence drug and gene interaction
Time Frame
Measured at completion of genetic analysis
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Study Population Description
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.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce M. Psaty, MD, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Health Research Unit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs
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