KYOTO
Add-on Effects of Valsartan on Morbi- Mortality
|
Status:
This study is ongoing, but not recruiting participants.
Purpose:
To assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.
Interventions:
Valsartan
Valsartan is an angiotensin II receptor antagonist (more commonly called an "ARB", which stands for Angiotensin Receptor Blocker), acting on the AT1 subtype.
|
Year Started:
2004
Design:
Interventional, Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Clinical diagnosis of hypertension; clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH).
Exclusion Criteria
Patients who have already been administered ARB; patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG);
severe/malignant/secondary hypertensive patients; pregnant women and women of childbearing potential; history of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months; arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block; severe renal impairment (Serum creatinine >3.0 mg/dl); severe hepatic impairment (Hepatic failure, Cirrhosis, etc.).
Patient Involvement:
Patients will be randomized to one of two arms: 1) conventional treatment group: conventional treatment with antihypertensive drugs other than ARB and ACEI are provided or 2) Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary. Follow-up will be for 5 years after enrollment.
Primary Outcome:
New onset or recurrence of stroke; new onset or recurrence of transient ischemic attack; new onset or recurrence of acute myocardial infarction; hospitalization due to the new onset, recurrence or worsening of heart failure and additional concomitant use of other anti-heart failure agents or increase of dosage; hospitalization due to the new onset, occurrence or worsening of angina pectoris and additional concomitant use of other anti-anginal agents or increase of dosage; operation of PCI or bypass operation;
new onset of acute dissecting aneurysm of the aorta; new onset, recurrence or worsening of arteriosclerosis obliterans; transition to dialysis, doubling of plasma Cr levels.
Secondary Outcome:
All cause mortality; worsening of cardiac function; new onset or worsening of arrhythmias; new onset or worsening of diabetes mellitus or IGT; uncontrolled blood pressure, etc.
Source of Information:
ClinicalTrials.gov
|
|
Web Links and Publications:
|
|
This information last updated on: 9/28/2009
Reviewed on: 09/28/2009.
|
Trials
Directories