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

Kumamoto University

Status and phase

Terminated

Phase 4

Conditions

Hypertension

Treatments

Drug: valsartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00140790

CVM-RCT-2005-02

Details and patient eligibility

About

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.

Full 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

Enrollment

1,000 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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