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

Information source: Kumamoto University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Kumamoto University

Official(s) and/or principal investigator(s):
Hisao Ogawa, MD, PhD, Study Chair, Affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

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.

Clinical Details

Official title: Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Cardiovascular events

End-stage renal dysfunction

50% reduction of creatinine clearance

Secondary outcome:

% FS and E/A ratio

Specific biochemical markers for cardiac or renal function

% changes of creatinine clearance

1/(serum Cr)

Serum K

HbA1c

U-prot/U-Cr

Adverse drug effects

New onset Atrial Fibrillation

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

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan

Department of Cardiovascular Medicine, Kumamoto University Hospital, Kumamoto 860-8556, Japan

Additional Information

Starting date: August 2006
Last updated: October 11, 2013

Page last updated: August 20, 2015

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