NCT00573092

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

9.2 years

First QC Date

December 12, 2007

Last Update Submit

November 7, 2016

Conditions

Keywords

Cardiovascular EpidemiologyGenomicsGenome-Wide Association Study

Outcome Measures

Primary Outcomes (1)

  • Genomic regions for each of the four major drug classes that influence drug and gene interaction

    Measured at completion of genetic analysis

Secondary Outcomes (1)

  • Ethnic-specific genetic variations for each of the four major drug classes that influence drug and gene interaction

    Measured at completion of genetic analysis

Study Arms (1)

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

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Health Research Unit

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionStrokeDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart ArrestDeath, SuddenDeath

Study Officials

  • Bruce M. Psaty, MD, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Medicine & Epidemiology

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations