Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005332
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2000-05-25
Brief Title:
Antihypertensive DrugGene Interactions and CV Events
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate drug-gene interactions on the incidence of non-fatal myocardial infarction and stroke for hypertensive patients
Detailed Description:
BACKGROUND
The original study Calcium-Channel Blockers and Primary Prevention of Coronary Heart Disease was conducted from 1991 to 1995 and was designed to determine whether the calcium-channel blockers reduced the incidence of myocardial infarction MI in patients with hypertension Secondary aims included the evaluation of the relative efficacy and safety of other major drug classes including ACE inhibitors beta-blockers and alpha blockers The study originated to answer questions concerning the 1988 recommendations from the Joint National Committee on Detection Evaluation and Treatment of High Blood Pressure JNC V The 1988 recommendations from the Joint National Committee revolutionized the step-care approach to the treatment of hypertension the calcium- channel blockers a then new class of agents were included as first-line agents That they lowered blood pressure was clear But no randomized trial had yet evaluated their safety and efficacy in terms of the clinical endpoints of stroke and coronary heart disease Because the results of previous randomized trials suggested that the treatment of hypertension did not reduce the incidence of coronary heart disease the study was designed to answer that question
In 1995 the study was renewed as Antihypertensive Medications MI and Stroke and was designed to to determine whether calcium-channel blockers increased the risk of stroke among hypertensive patients and whether individual calcium-channel blockers representing the three major subclasses increased the risks of MI and of the combined endpoint of MI and stroke in patients with hypertension
DESIGN NARRATIVE
The study has a case-control design Data collected from the Group Health Cooperative GHC computerized files were used to identify potential cases all treated hypertensive patients aged 30 to 79 years were eligible as cases if according to WHO criteria they presented with an incident fatal or non-fatal MI A random sample of members listed in the GHC enrollment files served as the source of potential controls Review of the outpatient medical records ensured that all study subjects met the same entrance criteria The effort also secured information about blood pressures duration of hypertension and past medical history A telephone interview provided information about other potential confounders including smoking diet and physical activity The GHC computerized pharmacy records a database of all prescriptions filled by enrollees served as the primary source of information about the use of calcium-channel blockers Frequency matching controlled for the potential confounding effects of age and year of presentation and data analysis involved logistic regression
The study has been renewed twice The first renewal was for an additional five years through May 2000 in order to identify an estimated additional 1007 stroke cases an additional 1020 MI cases and an additional 2500 controls The second renewal was through August 2005 to determine antihypertensive druggene interactions and cardiovascular events The ongoing second renewal focuses on drug-gene interactions on the incidence of non-fatal myocardial infarction and stroke for hypertensive patients emphasizing 1 the alpha adducin polymorphism and diuretic use 2 the beta-2 adrenergic receptor-27 B2AR27 polymorphism and beta-blockers and 3 the ACE insertiondeletion polymorphism and the ACE inhibitor use The study also assesses other potential gene-drug interactions with the G-protein beta-3 subunit GB3 polymorphism B2AR-16 polymorphism the amiloride-sensitive epithelial sodium channel and the angiotensinogen Met235Thr polymorphism In addition for fatal cases DNA extracted from surgical or pathological specimens will be used to assess genotypes
The original study Calcium-Channel Blockers and Primary Prevention of Coronary Heart Disease was conducted from 1991 to 1995 and was designed to determine whether the calcium-channel blockers reduced the incidence of myocardial infarction MI in patients with hypertension Secondary aims included the evaluation of the relative efficacy and safety of other major drug classes including ACE inhibitors beta-blockers and alpha blockers The study originated to answer questions concerning the 1988 recommendations from the Joint National Committee on Detection Evaluation and Treatment of High Blood Pressure JNC V The 1988 recommendations from the Joint National Committee revolutionized the step-care approach to the treatment of hypertension the calcium- channel blockers a then new class of agents were included as first-line agents That they lowered blood pressure was clear But no randomized trial had yet evaluated their safety and efficacy in terms of the clinical endpoints of stroke and coronary heart disease Because the results of previous randomized trials suggested that the treatment of hypertension did not reduce the incidence of coronary heart disease the study was designed to answer that question
In 1995 the study was renewed as Antihypertensive Medications MI and Stroke and was designed to to determine whether calcium-channel blockers increased the risk of stroke among hypertensive patients and whether individual calcium-channel blockers representing the three major subclasses increased the risks of MI and of the combined endpoint of MI and stroke in patients with hypertension
DESIGN NARRATIVE
The study has a case-control design Data collected from the Group Health Cooperative GHC computerized files were used to identify potential cases all treated hypertensive patients aged 30 to 79 years were eligible as cases if according to WHO criteria they presented with an incident fatal or non-fatal MI A random sample of members listed in the GHC enrollment files served as the source of potential controls Review of the outpatient medical records ensured that all study subjects met the same entrance criteria The effort also secured information about blood pressures duration of hypertension and past medical history A telephone interview provided information about other potential confounders including smoking diet and physical activity The GHC computerized pharmacy records a database of all prescriptions filled by enrollees served as the primary source of information about the use of calcium-channel blockers Frequency matching controlled for the potential confounding effects of age and year of presentation and data analysis involved logistic regression
The study has been renewed twice The first renewal was for an additional five years through May 2000 in order to identify an estimated additional 1007 stroke cases an additional 1020 MI cases and an additional 2500 controls The second renewal was through August 2005 to determine antihypertensive druggene interactions and cardiovascular events The ongoing second renewal focuses on drug-gene interactions on the incidence of non-fatal myocardial infarction and stroke for hypertensive patients emphasizing 1 the alpha adducin polymorphism and diuretic use 2 the beta-2 adrenergic receptor-27 B2AR27 polymorphism and beta-blockers and 3 the ACE insertiondeletion polymorphism and the ACE inhibitor use The study also assesses other potential gene-drug interactions with the G-protein beta-3 subunit GB3 polymorphism B2AR-16 polymorphism the amiloride-sensitive epithelial sodium channel and the angiotensinogen Met235Thr polymorphism In addition for fatal cases DNA extracted from surgical or pathological specimens will be used to assess genotypes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL043201 | NIH | None | httpsreporternihgovquickSearchR01HL043201 |