NCT00140790

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

Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Kumamoto University · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	valsartan	valsartan 40 or 160 (80) mg per day

Timeline

• Start date: 2006-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2005-09-01
• Last updated: 2016-02-26

Locations

2 sites across 1 country: Japan