A Morbidity-Mortality and Remodeling Study With Valsartan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133328
Recruitment Status : Unknown
Verified January 2002 by Jikei University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : August 23, 2005
Last Update Posted : October 28, 2005
Information provided by:
Jikei University School of Medicine

Brief Summary:
The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.

Condition or disease Intervention/treatment Phase
Hypertension Ischemic Heart Disease Congestive Heart Failure Drug: valsartan Phase 4

Detailed Description:
Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. However, it is a problem that the number of Asian patients is very little in these trials. The researchers examine the treatment meaning by ARB about the prognosis of the patient who amalgamates either among high blood pressure, the ischemic heart disease, and congestive heart failures.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
Study Start Date : January 2002
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan
U.S. FDA Resources

Primary Outcome Measures :
  1. stroke
  2. new or recurrent transient ischemic attack
  3. new or recurrent acute myocardial infarction
  4. new occurrence or exacerbation of heart failure
  5. new occurrence or exacerbation angina pectoris
  6. dissecting aneurysm of the aorta
  7. lower limb arterial obstruction
  8. transition to dialysis
  9. doubling of plasma creatinine (Cr) levels

Secondary Outcome Measures :
  1. death from any cause
  2. left ventricular hypertrophy
  3. changes in ECG
  4. proteinuria
  5. B-type natriuretic peptide (BNP)
  6. heart failure symptoms
  7. heart failure syndrome (edema, rales on auscultation)
  8. blood pressure and heart rate

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure

Exclusion Criteria:

  • Pregnancy
  • Severe renal damage
  • Severe liver damage
  • Acute myocardial infarction

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 identifier (NCT number): NCT00133328

The Jikei University School of Medicine
Tokyo, Japan, 105-8461
Sponsors and Collaborators
Jikei University School of Medicine
Study Chair: Seibu Mochizuki, MD., PhD The Jikei University School of Medicine

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00133328     History of Changes
Other Study ID Numbers: JHS2002
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: October 28, 2005
Last Verified: January 2002

Keywords provided by Jikei University School of Medicine:
myocardial infarction
renal damage

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