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A Morbidity-Mortality and Remodeling Study With Valsartan

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2002 by Jikei University School of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133328
First Posted: August 23, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Jikei University School of Medicine
  Purpose
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 Intervention Phase
Hypertension Ischemic Heart Disease Congestive Heart Failure Drug: valsartan Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jikei University School of Medicine:

Primary Outcome Measures:
  • stroke
  • new or recurrent transient ischemic attack
  • new or recurrent acute myocardial infarction
  • new occurrence or exacerbation of heart failure
  • new occurrence or exacerbation angina pectoris
  • dissecting aneurysm of the aorta
  • lower limb arterial obstruction
  • transition to dialysis
  • doubling of plasma creatinine (Cr) levels

Secondary Outcome Measures:
  • death from any cause
  • left ventricular hypertrophy
  • changes in ECG
  • proteinuria
  • B-type natriuretic peptide (BNP)
  • heart failure symptoms
  • heart failure syndrome (edema, rales on auscultation)
  • blood pressure and heart rate

Estimated Enrollment: 3000
Study Start Date: January 2002
Estimated Study Completion Date: November 2005
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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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): NCT00133328


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00133328     History of Changes
Other Study ID Numbers: JHS2002
First Submitted: August 22, 2005
First Posted: August 23, 2005
Last Update Posted: December 9, 2005
Last Verified: January 2002

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

Additional relevant MeSH terms:
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