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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00006294 |
To examine whether the association between selected hypertensive genes and combined fatal coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is modified by the type of antihypertensive treatment, leading to differential risks of coronary heart disease.
Condition | Phase |
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Cardiovascular Diseases Heart Diseases Hypertension Coronary Disease Myocardial Infarction |
N/A |
Study Type: | Observational |
Study Start Date: | September 1999 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
BACKGROUND:
The study might shed important light on the variation in patient response to antihypertensive agents, and improve the ability to pick the right antihypertensive for specific patients. GenHAT is an ancillary study to ALLHAT (the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). ALLHAT recruited 42,515 hypertensives and randomized them to one of four antihypertensive agents (lisinopril, chlorthalidone, amlodipine, and doxazosin); follow-up will be completed in March, 2002.
DESIGN NARRATIVE:
GenHAT, a prospective study ancillary to ALLHAT, will characterize hypertension genetic variants and determine their interaction with antihypertensive treatments in relation to coronary heart disease (CHD). DNA from frozen clots stored at the ALLHAT Central Laboratory will be used to genotype variants of hypertension genes (angiotensinogen -6, angiotensin converting enzyme insertion/deletion, angiotensin type- 1 receptor, alpha-adducin, beta2 adrenergic receptor, lipoprotein lipase, and 10 new hypertension variants expected to be discovered during the course of the study).
In addition to the primary aim, a number of secondary aims will be undertaken to evaluate gene- treatment interactions in relation to other endpoints, including all-cause mortality, stroke, heart failure, left ventricular hypertrophy, decreased renal function, peripheral arterial disease, and blood pressure lowering. Because of the ethnic and gender diversity of ALLHAT, an assessment will be made of the effects of these variants on outcomes in key subgroups (age >65 years, women, African Americans, Type II diabetics), and whether the gene-treatment interactions in relation to outcomes are consistent across subgroups.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 911 |
Study First Received: | September 25, 2000 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00006294 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Arteriosclerosis Ischemia Infarction Myocardial Infarction Coronary Artery Disease Hypertension |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Disease |
Necrosis Pathologic Processes Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease Hypertension |