Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)

Stroke Clinical Trial

Official title: Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension

Status Completed

Clinical Trial Summary

The KYOTO HEART Study is 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.

Clinical Trial Description

Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality. ;

Study Design

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Hypertension
• Ischemic Heart Disease
• Myocardial Ischemia
• Stroke

• NCT number: NCT00149227
• Study type: Interventional
• Source: Kyoto Prefectural University of Medicine
• Status: Completed
• Phase: Phase 4
• Start date: January 2004
• Completion date: January 2009