Clinical trial NCT00149227: Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
Official title: Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Kyoto Prefectural University of Medicine
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 3031
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: New Onset or Recurrence of Stroke
timeFrame: five years
measure: New Onset or Recurrence of Transient Ischemic Attack
timeFrame: five years
measure: New Onset or Recurrence of Acute Myocardial Infarction
timeFrame: five years
measure: 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
timeFrame: five years
measure: 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
timeFrame: five years
measure: Operation of PCI or Bypass Operation
timeFrame: five years
measure: New Onset of Acute Dissecting Aneurysm of the Aorta
timeFrame: five years
measure: New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans
timeFrame: five years
measure: Transition to Dialysis, Doubling of Plasma Cr Levels
timeFrame: five years
Secondary outcomes:
measure: All Cause Mortality
timeFrame: five years
measure: Worsening of Cardiac Function
timeFrame: five years
measure: New Onset or Worsening of Arrhythmias
timeFrame: five years
measure: New Onset or Worsening of Diabetes Mellitus or IGT
timeFrame: five years
measure: Uncontrolled Blood Pressure, Etc.
timeFrame: five years
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hiroaki Matsubara, MD,PhD
role: STUDY_CHAIR
References:
citation: Sawada T, Takahashi T, Yamada H, Dahlof B, Matsubara H; KYOTO HEART Study Group. Rationale and design of the KYOTO HEART study: effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high risk of cardiovascular events. J Hum Hypertens. 2009 Mar;23(3):188-95. doi: 10.1038/jhh.2008.116. Epub 2008 Sep 18.
citation: Sawada T, Yamada H, Dahlof B, Matsubara H; KYOTO HEART Study Group. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study. Eur Heart J. 2009 Oct;30(20):2461-9. doi: 10.1093/eurheartj/ehp363. Epub 2009 Aug 31.