Hypertension
Conditions
Keywords
Cardiorenal syndrome, Renal dysfunction, Cardiovascular events, Valsartan
Brief 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.
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
Interventions
DRUGvalsartan
valsartan 40 or 160 (80) mg per day
Sponsors
Kumamoto University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular events | 2 years |
| End-stage renal dysfunction | 2 years |
| 50% reduction of creatinine clearance | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 1/(serum Cr) | 2 years |
| Serum K | 2 years |
| HbA1c | 2 years |
| % FS and E/A ratio | 2 years |
| Adverse drug effects | 2 years |
| New onset Atrial Fibrillation | 2 years |
| U-prot/U-Cr | 2 years |
| Specific biochemical markers for cardiac or renal function | 6 months and 1 year and 2 years |
| % changes of creatinine clearance | 2 years |
Countries
Japan
Outcome results
None listed