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

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ClinicalTrials.gov Identifier: NCT00149227
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : December 12, 2012
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
Hiroaki Matsubara, MD., PhD, Kyoto Prefectural University of Medicine

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.

Condition or disease Intervention/treatment Phase
Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke Drug: Valsartan Drug: Non-ARB Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3031 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension
Study Start Date : January 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arm Intervention/treatment
Active Comparator: Non-ARB
'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs
Drug: Non-ARB
'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs
Other Name: Conventional anti-hypertensive treatment

Experimental: Valsartan
Valsartan add-on treatment
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.
Other Name: Diovan




Primary Outcome Measures :
  1. New Onset or Recurrence of Stroke [ Time Frame: five years ]
    Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  2. New Onset or Recurrence of Transient Ischemic Attack [ Time Frame: five years ]
    Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  3. New Onset or Recurrence of Acute Myocardial Infarction [ Time Frame: five years ]
    Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  4. 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 ]
    Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  5. 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 ]
    Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  6. Operation of PCI or Bypass Operation [ Time Frame: five years ]
  7. New Onset of Acute Dissecting Aneurysm of the Aorta [ Time Frame: five years ]
    Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  8. New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans [ Time Frame: five years ]
    Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  9. Transition to Dialysis, Doubling of Plasma Cr Levels [ Time Frame: five years ]
    The first of any events, "transition to dialysis" or "doubling of plasma Cr levels compared to the entry", occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.


Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: five years ]
  2. Worsening of Cardiac Function [ Time Frame: five years ]
  3. New Onset or Worsening of Arrhythmias [ Time Frame: five years ]
  4. New Onset or Worsening of Diabetes Mellitus or IGT [ Time Frame: five years ]
    Diabetes mellitus was defined as fasting plasma glucose >=126 mg/dl, causal blood glucose >= 200 mg /dl, HbA1C >= 6.5%, and/or plasma glucose 2hr after 75g glucose load >= 200 mg/dl. The first of these events, "new onset diabetes" or "worsening diabetes following IGT", occurring in a specific patient was classified as an event to be counted in the secondary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level.

  5. Uncontrolled Blood Pressure, Etc. [ Time Frame: five years ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149227


Locations
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Japan
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Sponsors and Collaborators
Kyoto Prefectural University of Medicine
Investigators
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Study Chair: Hiroaki Matsubara, MD,PhD Kyoto Prefectural University of Medicine

Publications of Results:
Other Publications:
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Responsible Party: Hiroaki Matsubara, MD., PhD, Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension, Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier: NCT00149227     History of Changes
Other Study ID Numbers: KHS2004
First Posted: September 8, 2005    Key Record Dates
Results First Posted: December 12, 2012
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Hiroaki Matsubara, MD., PhD, Kyoto Prefectural University of Medicine:
High risk hypertension
Ischemic heart disease
Angiotensin receptor blockers
Cardiovascular mortality- morbidity
KYOTO HEART Study

Additional relevant MeSH terms:
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Hypertension
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action