Trial record 4 of 4 for:    Sudden Cardiac Arrest | Open Studies | NIH, U.S. Fed

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
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
  Purpose

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.


Condition
Myocardial Infarction
Cerebrovascular Accident
Death, Sudden, Cardiac

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genome-Wide Case-Only Study of Antihypertensive Drug-Gene Interactions

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Previously collected and new samples with DNA


Estimated Enrollment: 7900
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573092

Contacts
Contact: Nicole L. Glazer, PhD, MPH 206-287-2777 nlg@u.washington.edu

Locations
United States, Washington
Cardiovascular Health Research Unit Recruiting
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Bruce M. Psaty, MD, PhD University of Washington
  More Information

No publications provided

Responsible Party: Bruce Psaty, Professor, Medicine & Epidemiology, University of Washington
ClinicalTrials.gov Identifier: NCT00573092     History of Changes
Other Study ID Numbers: 1411, R01HL085251-01A1, R01 HL085251-01A1
Study First Received: December 12, 2007
Last Updated: January 4, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Cardiovascular Epidemiology
Genomics
Genome-Wide Association Study

Additional relevant MeSH terms:
Death, Sudden
Death, Sudden, Cardiac
Heart Diseases
Heart Arrest
Hypertension
Infarction
Myocardial Infarction
Cerebral Infarction
Stroke
Death
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Ischemia
Necrosis
Myocardial Ischemia
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014