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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140790
Recruitment Status : 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.)
First Posted : September 1, 2005
Last Update Posted : February 26, 2016
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction
Study Start Date : August 2006
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 2 years ]
  2. End-stage renal dysfunction [ Time Frame: 2 years ]
  3. 50% reduction of creatinine clearance [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. % FS and E/A ratio [ Time Frame: 2 years ]
  2. Specific biochemical markers for cardiac or renal function [ Time Frame: 6 months and 1 year and 2 years ]
  3. % changes of creatinine clearance [ Time Frame: 2 years ]
  4. 1/(serum Cr) [ Time Frame: 2 years ]
  5. Serum K [ Time Frame: 2 years ]
  6. HbA1c [ Time Frame: 2 years ]
  7. U-prot/U-Cr [ Time Frame: 2 years ]
  8. Adverse drug effects [ Time Frame: 2 years ]
  9. New onset Atrial Fibrillation [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140790

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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
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Study Chair: Hisao Ogawa, MD, PhD Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
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Responsible Party: Hisao Ogawa, Professor, Kumamoto University Identifier: NCT00140790    
Other Study ID Numbers: CVM-RCT-2005-02
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Keywords provided by Hisao Ogawa, Kumamoto University:
Cardiorenal syndrome
Renal dysfunction
Cardiovascular events
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action