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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00140790
First received: August 31, 2005
Last updated: October 11, 2013
Last verified: October 2013

August 31, 2005
October 11, 2013
August 2006
December 2013   (final data collection date for primary outcome measure)
  • Cardiovascular events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • End-stage renal dysfunction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 50% reduction of creatinine clearance [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)
  • 50% or more than 25 ml/min reduction of creatinine clearance
Complete list of historical versions of study NCT00140790 on ClinicalTrials.gov Archive Site
  • % FS and E/A ratio [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Specific biochemical markers for cardiac or renal function [ Time Frame: 6 months and 1 year and 2 years ] [ Designated as safety issue: Yes ]
  • % changes of creatinine clearance [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 1/(serum Cr) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Serum K [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • U-prot/U-Cr [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Adverse drug effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • New onset Atrial Fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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
  • 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 microalbmin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)
Not Provided
Not Provided
 
Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study
Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypertension
Drug: valsartan
valsartan 40 or 160 (80) mg per day
Other Name: valsartan
  • Active Comparator: Valsartan 40mg
    Standard Dose valsartan
    Intervention: Drug: valsartan
  • Active Comparator: Valsartan 160mg
    High Dose valsartan
    Intervention: Drug: valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
December 2016
December 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00140790
CVM-RCT-2005-02
Yes
Hisao Ogawa, Kumamoto University
Kumamoto University
Not Provided
Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP