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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2015-03-31

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.

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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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Valsartan 40mg

Standard Dose valsartan

Group Type ACTIVE_COMPARATOR

valsartan

Intervention Type DRUG

valsartan 40 or 160 (80) mg per day

Valsartan 160mg

High Dose valsartan

Group Type ACTIVE_COMPARATOR

valsartan

Intervention Type DRUG

valsartan 40 or 160 (80) mg per day

Interventions

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valsartan

valsartan 40 or 160 (80) mg per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No