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A Morbidity-Mortality and Remodeling Study With Valsartan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2002 by Jikei University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Jikei University School of Medicine
ClinicalTrials.gov Identifier:
NCT00133328
First received: August 22, 2005
Last updated: October 27, 2005
Last verified: January 2002
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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

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

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, ischemic heart disease and congestive heart failure

Exclusion Criteria:

  • Pregnancy
  • Severe renal damage
  • Severe liver damage
  • Acute myocardial infarction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00133328     History of Changes
Other Study ID Numbers: JHS2002
Study First Received: August 22, 2005
Last Updated: October 27, 2005
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 23, 2013