Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Drug: valsartan

• Registration Number: NCT00140790
• Lead Sponsor: Kumamoto University

Brief Summary

The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day 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 grafting;Stroke or transient ischaemic attack, dissociation aneurysm of the aorta needing hospitalisation;Lower 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 E/A 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 1/(serum Cr) in patients whose u-prot/u-Cr is equal to or more than 1.0

* transition of serum K

* HbA1c

* New onset Atrial Fibrillation

* New onset Diabetes

Study Timeline

• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-01
• Study Start: 2006-08
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan 40mg	valsartan	Standard Dose valsartan
Valsartan 160mg	valsartan	High Dose valsartan

Primary Outcome Measures

Name	Time	Method
Cardiovascular events	2 years
End-stage renal dysfunction	2 years
50% reduction of creatinine clearance	2 years

Secondary Outcome Measures

Name	Time	Method
1/(serum Cr)	2 years
U-prot/U-Cr	2 years
Adverse drug effects	2 years
New onset Atrial Fibrillation	2 years
% FS and E/A ratio	2 years
Specific biochemical markers for cardiac or renal function	6 months and 1 year and 2 years
% changes of creatinine clearance	2 years
Serum K	2 years
HbA1c	2 years

Trial Locations

Locations (2)

Department of Cardiovascular Medicine, Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University; 🇯🇵 Kumamoto, Japan