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

Hypertension Clinical Trial

Official title:

Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00140790
• Other study ID #: CVM-RCT-2005-02
• Status: Terminated
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: February 25, 2016
• Start date: August 2006
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Renal Insufficiency

Intervention

Drug:
• valsartan
valsartan 40 or 160 (80) mg per day

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University	Kumamoto
Japan	Department of Cardiovascular Medicine, Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events		2 years	Yes
Primary	End-stage renal dysfunction		2 years	Yes
Primary	50% reduction of creatinine clearance		2 years	Yes
Secondary	% FS and E/A ratio		2 years	Yes
Secondary	Specific biochemical markers for cardiac or renal function		6 months and 1 year and 2 years	Yes
Secondary	% changes of creatinine clearance		2 years	Yes
Secondary	1/(serum Cr)		2 years	Yes
Secondary	Serum K		2 years	Yes
Secondary	HbA1c		2 years	Yes
Secondary	U-prot/U-Cr		2 years	Yes
Secondary	Adverse drug effects		2 years	Yes
Secondary	New onset Atrial Fibrillation		2 years	Yes