Genetics of Hypertension Associated Treatments (GenHAT)

Completed

• Conditions: Hypertension; Heart Diseases; Coronary Disease; Myocardial Infarction; Cardiovascular Diseases
• Interventions: Drug: Chlorthalidone; Drug: Lisinopril; Drug: Amlodipine; Drug: Doxazosin

• Registration Number: NCT00006294
• Lead Sponsor: Donna Arnett, 257-5678

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2000-09-25
• Study First Submitted QC: 2000-09-25
• Study First Posted: 2000-09-26
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37939

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chlorthalidone	Chlorthalidone	Participants will take chlorthalidone at recommended doses to control hypertension
Lisinopril	Lisinopril	Participants will take Lisinopril at recommended doses to control hypertension
Amlodipine	Amlodipine	Participants will take Amlodipine at recommended doses to control hypertension
Doxazosin	Doxazosin	Participants will take Doxazosin at recommended doses to control hypertension

Primary Outcome Measures

Name	Time	Method
Blood Pressure	baseline and six month	Blood pressure will be measured to determine the effect of the prescribed anti-hypertensive . Data will be presented as the change in blood pressure over the course of six months

Secondary Outcome Measures

Name	Time	Method
Effect of genotype on event rates	6 years	The rate of fatal myocardial infarction (MI) was evaluated in relation to the ACE I/D genotype and anti-hypertensive used. Data are presented as the incidence of fatal MI after six years of follow up

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States