Analyzing How Genetics May Affect Response to High Blood Pressure Medications

This study has been completed.
Sponsor:
Collaborators:
University of Texas
University of Minnesota - Clinical and Translational Science Institute
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00563901
First received: November 21, 2007
Last updated: March 2, 2014
Last verified: January 2008
  Purpose

High blood pressure is one of the most common health problems in the United States. There are many medications to treat high blood pressure, but there is a large variance in how people respond to these medications. It is believed that genetic variations may contribute to the inconsistent treatment response. This study will use genetic analysis to determine whether particular genes interact with high blood pressure medications to modify the risk of certain cardiovascular diseases.


Condition
Hypertension
Coronary Disease
Cerebrovascular Accident

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: GenHAT - Genetics of Hypertension Associated Treatments - Ancillary to ALLHAT

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Candidate genes that interact with ALLHAT high blood pressure medications to modify risk of other cardiovascular conditions [ Time Frame: Measured at completion of genetic analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Within selected candidate genes, effect of multiple gene interactions with high blood pressure medications in modifying risk of other cardiovascular conditions [ Time Frame: Measured at completion of genetic analysis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples with DNA


Enrollment: 37939
Study Start Date: September 2000
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adults with a high risk for high blood pressure from the ALLHAT study

Detailed Description:

High blood pressure affects nearly one in three individuals in the Unites 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 coronary heart disease (CHD), stroke, heart attack, and heart failure. While high blood pressure can be managed with medication, people receiving medication treatment for high blood pressure are still variably at risk for CHD and other cardiovascular conditions. This risk variation may stem from varying drug reactions that are likely due to genetics. This study will use genetic analysis to determine whether particular genes interact with high blood pressure medications to modify the risk of certain cardiovascular diseases.

This is a continuation study to the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT), which included a randomized trial of the four high blood pressure drugs chlorthalidone, amlodipine, lisinopril, and doxazosin. Using samples from ALLHAT participants, this study will analyze the interactions of candidate gene pathways of relevance with medications from the ALLHAT study. Researchers will examine both single DNA building blocks and multiple genes in the candidate gene pathways and determine whether their interaction with the ALLHAT drugs modifies the risk of cardiovascular outcomes. Researchers will perform genetic analysis on 96 genetic markers using structured association testing (SAT) and false discovery rate (FDR) methods. These methods will control for population stratification and multiple testing. Finally, the study will establish a mechanism for other researchers to continue further analysis of the genetic variants examined in this study.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population samples will be taken from adults who are high risk for high blood pressure in the ALLHAT study, which included a randomized trial of the four high blood pressure drugs chlorthalidone, amlodipine, lisinopril, and doxazosin.

Criteria

Inclusion Criteria:

  • Participant in the ALLHAT study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563901

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Texas
University of Texas Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Alabama at Birmingham
University of Texas
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Donna K. Arnett, PhD University of Alabama at Birmingham
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donna K. Arnett, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00563901     History of Changes
Other Study ID Numbers: 1402, R01HL063082-07A1, R01 HL063082-07A1
Study First Received: November 21, 2007
Last Updated: March 2, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
CHD
Combined CHD
Stroke
Combined Cardiovascular Disease (CVD)
Pharmacogenetics
End-Stage Renal Disease
Heart Failure
Hospitalized/Fatal Heart Failure
Angina
Coronary Revascularizations
CHD Mortality
Lisinopril
Chlorthalidone
Amlodipine
Doxazosin

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Hypertension
Cerebral Infarction
Stroke
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014