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A Morbi-Mortality and Remodeling Study with Valsartan - Article


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Ischemic Heart Disease

Clinical Trial: A Morbi-Mortality and Remodeling Study with Valsartan

This study is no longer recruiting patients.

Sponsored by: Jikei University School of Medicine
Information provided by: Jikei University School of Medicine
ClinicalTrials.gov Identifier: NCT00133328

Purpose

The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an 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 IV

MedlinePlus related topics:  Coronary Disease;   Heart Diseases;   Heart Failure;   High Blood Pressure;   Vascular Diseases

Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Morbi-Mortality and Remodeling Study with Valsartan in Patients with Hypertension and Cardiovascular Disease

Further Study Details: 
Primary Outcomes: 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 Cr levels
Secondary Outcomes: 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
Expected Total Enrollment:  3000

Study start: January 2002;  Study completion: November 2005
Last follow-up: November 2005;  Data entry closure: November 2005

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 for which it is left that the number of Asian''''s patients is very little in these trials.　 We 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   -   79 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Location Information


Japan
      The Jikei University School of Medicine, Tokyo,  105-8461,  Japan

Study chairs or principal investigators

Seibu Mochizuki, MD.,PhD,  Study Chair,  The Jikei University School of Medicine   
Seibu Mochizuki, MD.PhD.,  Study Chair,  The Jikei University School of Medicine   

More Information

Publications that report results of this study

Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlof B; The JIKEI HEART Study Group. JIKEI HEART Study--a morbi-mortality and remodeling study with valsartan in Japanese patients with hypertension and cardiovascular disease. Cardiovasc Drugs Ther. 2004 Jul;18(4):305-9.

Study ID Numbers:  JHS2002
Last Updated:  August 22, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133328
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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Page Updated: September 6, 2005
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