Overview

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

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kumamoto University
Treatments:
Valsartan
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