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
  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
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 ]

Estimated Enrollment: 1500
Study Start Date: August 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2013 (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
Other Name: valsartan
Active Comparator: Valsartan 160mg
High Dose valsartan
Drug: valsartan
valsartan 40 or 160 (80) mg per day
Other Name: valsartan

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hisao Ogawa, Professor, Kumamoto University
ClinicalTrials.gov Identifier: NCT00140790     History of Changes
Other Study ID Numbers: CVM-RCT-2005-02
Study First Received: August 31, 2005
Last Updated: October 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014