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

Hypertension Clinical Trial

Official title: Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Renal Insufficiency

• NCT number: NCT00140790
• Study type: Interventional
• Source: Kumamoto University
• Status: Terminated
• Phase: Phase 4
• Start date: August 2006
• Completion date: March 2015