Clinical trial NCT00140790: Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study
Official title: Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Keywords: Cardiorenal syndrome
Renal dysfunction
Cardiovascular events
Valsartan
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2005-09-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility 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

Primary outcomes:
measure: Cardiovascular events
timeFrame: 2 years
measure: End-stage renal dysfunction
timeFrame: 2 years
measure: 50% reduction of creatinine clearance
timeFrame: 2 years
Secondary outcomes:
measure: % FS and E/A ratio
timeFrame: 2 years
measure: Specific biochemical markers for cardiac or renal function
timeFrame: 6 months and 1 year and 2 years
measure: % changes of creatinine clearance
timeFrame: 2 years
measure: 1/(serum Cr)
timeFrame: 2 years
measure: Serum K
timeFrame: 2 years
measure: HbA1c
timeFrame: 2 years
measure: U-prot/U-Cr
timeFrame: 2 years
measure: Adverse drug effects
timeFrame: 2 years
measure: New onset Atrial Fibrillation
timeFrame: 2 years
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
city: Kumamoto
country: Japan
facility: Department of Cardiovascular Medicine, Kumamoto University Hospital
Study officials:
affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
name: Hisao Ogawa, MD, PhD
role: STUDY_CHAIR
References: