Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140790
Status:
TERMINATED
Last Update Posted:
2016-02-26
First Post:
2005-08-31
Brief Title:
Valsartan in Cardiovascular Disease With Renal Dysfunction The V-CARD Study
Sponsor:
Kumamoto University
Organization:
Kumamoto University
Study Overview
Official Title:
Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The number of actual events was extremely low We extended the study period but it was still not enough Also many patients were loss of follow up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate if an angiotensin II receptor blocker valsartan 160 mgday is more effective to reduce the incidence of cardiovascular events as compared to 40 mgday in patients with moderate renal dysfunction
Detailed Description:
It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases That is called cardiorenal syndrome It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function
The primary endpoints are
cardiovascular events cardiac death non-fatal myocardial infarction unstable angina requiring rehospitalization congestive heart failure requiring rehospitalization revascularization procedures including coronary angioplasty or coronary artery bypass graftingStroke or transient ischaemic attack dissociation aneurysm of the aorta needing hospitalisationLower limbs artery obstruction needing hospitalisation
end-stage renal dysfunction introduction of hemodialysis or kidney transplantation
50 reduction of creatinine clearance
The secondary endpoints are
systolic and diastolic function of the left ventricle estimated by echocardiography FS and EA ratio
specific biochemical markers for cardiac or renal function urine microalbumin plasma B-type natriuretic peptide plasma type 1 plasminogen activator inhibitor plasma cystatin C
changes of creatinine clearance between start and end of the study period
transition of 1serum Cr in patients whose u-protu-Cr is equal to or more than 10
transition of serum K
HbA1c
New onset Atrial Fibrillation
New onset Diabetes
The primary endpoints are
cardiovascular events cardiac death non-fatal myocardial infarction unstable angina requiring rehospitalization congestive heart failure requiring rehospitalization revascularization procedures including coronary angioplasty or coronary artery bypass graftingStroke or transient ischaemic attack dissociation aneurysm of the aorta needing hospitalisationLower limbs artery obstruction needing hospitalisation
end-stage renal dysfunction introduction of hemodialysis or kidney transplantation
50 reduction of creatinine clearance
The secondary endpoints are
systolic and diastolic function of the left ventricle estimated by echocardiography FS and EA ratio
specific biochemical markers for cardiac or renal function urine microalbumin plasma B-type natriuretic peptide plasma type 1 plasminogen activator inhibitor plasma cystatin C
changes of creatinine clearance between start and end of the study period
transition of 1serum Cr in patients whose u-protu-Cr is equal to or more than 10
transition of serum K
HbA1c
New onset Atrial Fibrillation
New onset Diabetes
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