- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573092
Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs
Genome-Wide Case-Only Study of Antihypertensive Drug-Gene Interactions
Study Overview
Status
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.
Study Type
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98101
- Cardiovascular Health Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Genomic regions for each of the four major drug classes that influence drug and gene interaction
Time Frame: Measured at completion of genetic analysis
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Measured at completion of genetic analysis
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Measured at completion of genetic analysis
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce M. Psaty, MD, PhD, University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Death
- Heart Arrest
- Myocardial Infarction
- Infarction
- Stroke
- Death, Sudden, Cardiac
- Death, Sudden
Other Study ID Numbers
- 1411
- R01HL085251-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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