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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: valsartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (all required): Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP) >/= 90 (untreated hypertension cases); or SBP>/=130 and/or DBP>/=80 (treated hypertension cases) Patients with coronary artery disease (more than 50% stenosis on coronary angiography [CAG], coronary computed tomography [CT] or coronary magnetic resonance angiography [MRA]; coronary spasm; or history of percutaneous coronary intervention [PCI]);Unstable angina patient Creatinine clearance between 30.0 and 89.9 ml/min Exclusion Criteria (at least one of following): Reduced left ventricular (LV) function (ejection fraction [EF] equal to or less than 40%) Hyperpotassemia (serum potassium equal to or more than 5.5 mEq/l) Rapid progressive glomerular nephritis Nephrotic syndrome Renal artery stenosis Uncontrolled diabetes (HbA1c equal to or more than 9.0%) History of allergy to valsartan Pregnant women

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Valsartan 40mg<br>Standard Dose valsartan | Drug: valsartan<br>* valsartan 40 or 160 (80) mg per day<br>|
| Active Comparator: Valsartan 160mg<br>High Dose valsartan | Drug: valsartan<br>* valsartan 40 or 160 (80) mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events |  | 2 years | 
| End-stage renal dysfunction |  | 2 years | 
| 50% reduction of creatinine clearance |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 | 
| 1/(serum Cr) |  | 2 years | 
| Serum K |  | 2 years | 
| HbA1c |  | 2 years | 
| U-prot/U-Cr |  | 2 years | 
| Adverse drug effects |  | 2 years | 
| New onset Atrial Fibrillation |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiorenal syndrome, Renal dysfunction, Cardiovascular events, Valsartan