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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborators: |
University of Texas University of Minnesota - Clinical and Translational Science Institute |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00563901 |
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 |
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
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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 |
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.
Inclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Texas | |
| University of Texas Houston | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Donna K. Arnett, PhD | University of Alabama at Birmingham |
More Information
| Responsible Party: | Donna K. Arnett, PhD, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00563901 History of Changes |
| Other Study ID Numbers: | 1402, R01 HL063082-07A1 |
| Study First Received: | November 21, 2007 |
| Last Updated: | March 6, 2008 |
| Health Authority: | United States: Federal Government |
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CHD Combined CHD Stroke Combined CVD Pharmacogenetics End-Stage Renal Disease Heart Failure Hospitalized/Fatal Heart Failure |
Angina Coronary Revascularizations CHD Mortality Lisinopril Chlorthalidone Amlodipine Doxazosin |
|
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 |