NCT00149227

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,031 (actual)
• Sponsor: Kyoto Prefectural University of Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hypertension
• Ischemic Heart Disease
• Congestive Heart Failure
• Stroke

Interventions

Type	Name	Description
DRUG	Valsartan	Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.
DRUG	Non-ARB	'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs

Timeline

• Start date: 2004-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-09-08
• Last updated: 2012-12-12
• Results posted: 2012-12-12

Locations

1 site across 1 country: Japan