Conditions: Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke
Keywords: High risk hypertension Ischemic heart disease Angiotensin receptor blockers Cardiovascular mortality- morbidity KYOTO HEART Study
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3031
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs arm 2: Valsartan add-on treatment

Interventions: intervention 1: Valsartan intervention 2: Non-ARB
Intervention descriptions: intervention 1: Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary. intervention 2: 'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs

Protocol document: