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

Sponsor:	Kyoto Prefectural University of Medicine
Information provided by:	Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier:	NCT00149227

Purpose

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.

Condition	Intervention	Phase
Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke	Drug: Valsartan	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases Heart Failure High Blood Pressure

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Kyoto Prefectural University of Medicine:

Primary Outcome Measures:

new onset or recurrence of stroke [ Time Frame: five years ] [ Designated as safety issue: No ]
new onset or recurrence of transient ischemic attack [ Time Frame: five years ] [ Designated as safety issue: No ]
new onset or recurrence of acute myocardial infarction [ Time Frame: five years ] [ Designated as safety issue: No ]
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 [ Time Frame: five years ] [ Designated as safety issue: No ]
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 [ Time Frame: five years ] [ Designated as safety issue: No ]
operation of PCI or bypass operation [ Time Frame: five years ] [ Designated as safety issue: No ]
new onset of acute dissecting aneurysm of the aorta [ Time Frame: five years ] [ Designated as safety issue: No ]
new onset, recurrence or worsening of arteriosclerosis obliterans [ Time Frame: five years ] [ Designated as safety issue: No ]
transition to dialysis, doubling of plasma Cr levels [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

all cause mortality [ Time Frame: five years ] [ Designated as safety issue: No ]
worsening of cardiac function [ Time Frame: five years ] [ Designated as safety issue: No ]
new onset or worsening of arrhythmias [ Time Frame: five years ] [ Designated as safety issue: No ]
new onset or worsening of diabetes mellitus or IGT [ Time Frame: five years ] [ Designated as safety issue: No ]
uncontrolled blood pressure, etc. [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment:	3000
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator conventional treatment group: conventional treatment with antihypertensive drugs other than ARB and ACEI are provided.	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.

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

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149227

Locations

Japan
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566

Sponsors and Collaborators

Kyoto Prefectural University of Medicine

Investigators

Study Chair:

Hiroaki Matsubara, MD,PhD

Kyoto Prefectural University of Medicine

More Information

No publications provided by Kyoto Prefectural University of Medicine

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sawada T, Yamada H, Dahlöf 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. Epub 2009 Aug 31.

Responsible Party:	Kyoto Prefectural University of Medicine ( Foundation for the Promotion of Medical Science )
Study ID Numbers:	KHS2004
Study First Received:	September 6, 2005
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00149227 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto Prefectural University of Medicine:

High risk hypertension
Ischemic heart disease
Angiotensin receptor blockers
Cardiovascular mortality- morbidity
KYOTO HEART Study

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Therapeutic Uses
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010