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

This study has been terminated.
(The number of actual events was extremely low. We extended the study period, but it was still not enough. Also, many patients were loss of follow up.)
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University Identifier:
First received: August 31, 2005
Last updated: February 25, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Drug: valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction

Resource links provided by NLM:

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • % 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 ]

Enrollment: 1000
Study Start Date: August 2006
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Valsartan 40mg
Standard Dose valsartan
Drug: valsartan
valsartan 40 or 160 (80) mg per day
Active Comparator: Valsartan 160mg
High Dose valsartan
Drug: valsartan
valsartan 40 or 160 (80) mg per day

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00140790

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Department of Cardiovascular Medicine, Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
  More Information

Responsible Party: Hisao Ogawa, Professor, Kumamoto University Identifier: NCT00140790     History of Changes
Other Study ID Numbers: CVM-RCT-2005-02 
Study First Received: August 31, 2005
Last Updated: February 25, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:
Cardiorenal syndrome
Renal dysfunction
Cardiovascular events

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2016