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

Information source: Kyoto Prefectural University of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Ischemic Heart Disease; Congestive Heart Failure; Stroke

Intervention: Valsartan (Drug); Non-ARB (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kyoto Prefectural University of Medicine

Official(s) and/or principal investigator(s):
Hiroaki Matsubara, MD,PhD, Study Chair, Affiliation: Kyoto Prefectural University of Medicine

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

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 outcome:

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.

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

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Both.

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.)

Locations and Contacts

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

Related publications:

Sawada T, Takahashi T, Yamada H, Dahlöf 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. Erratum in: J Hum Hypertens. 2013 Sep;27(9):580.

Starting date: January 2004
Last updated: December 9, 2012

Page last updated: August 20, 2015

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