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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140790
First Posted: September 1, 2005
Last Update Posted: February 26, 2016
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.
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
  Purpose
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
Hypertension Drug: valsartan Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hisao Ogawa, Kumamoto University:

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

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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00140790


Locations
Japan
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00140790     History of Changes
Other Study ID Numbers: CVM-RCT-2005-02
First Submitted: August 31, 2005
First Posted: September 1, 2005
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by Hisao Ogawa, Kumamoto University:
Cardiorenal syndrome
Renal dysfunction
Cardiovascular events
Valsartan

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action