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

Completed

Phase 4 Results

Trial Description

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

Interventions

  • Valsartan (Diovan,)Drug
    Intervention Desc: Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.
    ARM 1: Kind: Experimental
    Label: 2
    Description: conventional treatment group: conventional treatment with antihypertensive drugs other than ARB and ACEI are provided.
    ARM 2: Kind: Experimental
    Label: Valsartan
    Description: Valsartan add-on treatment
  • Non-ARB Drug
    Other Names: Conventional anti-hypertensive treatment
    Intervention Desc: 'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs
    ARM 1: Kind: Experimental
    Label: Non-ARB
    Description: 'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 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.
Primary new onset or recurrence of stroke five years No
Primary new onset or recurrence of transient ischemic attack five years No
Primary new onset or recurrence of acute myocardial infarction five years No
Primary 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 five years No
Primary 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 five years No
Primary operation of PCI or bypass operation five years No
Primary new onset of acute dissecting aneurysm of the aorta five years No
Primary new onset, recurrence or worsening of arteriosclerosis obliterans five years No
Primary transition to dialysis, doubling of plasma Cr levels five years No
Secondary all cause mortality five years No
Secondary worsening of cardiac function five years No
Secondary new onset or worsening of arrhythmias five years No
Secondary new onset or worsening of diabetes mellitus or IGT five years No
Secondary uncontrolled blood pressure, etc. five years No

Sponsors