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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 16, 2014