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A Morbidity-Mortality and Remodeling Study With Valsartan

Primary Purpose

Hypertension, Ischemic Heart Disease, Congestive Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
valsartan
Sponsored by
Jikei University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring stroke, myocardial infarction, angina, renal damage

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Jikei University School of Medicine

Outcomes

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

Full Information

First Posted
August 22, 2005
Last Updated
October 27, 2005
Sponsor
Jikei University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00133328
Brief Title
A Morbidity-Mortality and Remodeling Study With Valsartan
Official Title
A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jikei University School of Medicine

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Ischemic Heart Disease, Congestive Heart Failure
Keywords
stroke, myocardial infarction, angina, renal damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
valsartan
Primary Outcome Measure Information:
Title
stroke
Title
new or recurrent transient ischemic attack
Title
new or recurrent acute myocardial infarction
Title
new occurrence or exacerbation of heart failure
Title
new occurrence or exacerbation angina pectoris
Title
dissecting aneurysm of the aorta
Title
lower limb arterial obstruction
Title
transition to dialysis
Title
doubling of plasma creatinine (Cr) levels
Secondary Outcome Measure Information:
Title
death from any cause
Title
left ventricular hypertrophy
Title
changes in ECG
Title
proteinuria
Title
B-type natriuretic peptide (BNP)
Title
heart failure symptoms
Title
heart failure syndrome (edema, rales on auscultation)
Title
blood pressure and heart rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seibu Mochizuki, MD., PhD
Organizational Affiliation
The Jikei University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
The Jikei University School of Medicine
City
Tokyo
ZIP/Postal Code
105-8461
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15367828
Citation
Mochizuki S, Shimizu M, Taniguchi I, Kanae K, Yoshida S, Tajima N, Dahlof B; 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. doi: 10.1023/B:CARD.0000041250.00079.84.
Results Reference
result
PubMed Identifier
17467513
Citation
Mochizuki S, Dahlof B, Shimizu M, Ikewaki K, Yoshikawa M, Taniguchi I, Ohta M, Yamada T, Ogawa K, Kanae K, Kawai M, Seki S, Okazaki F, Taniguchi M, Yoshida S, Tajima N; Jikei Heart Study group. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28;369(9571):1431-1439. doi: 10.1016/S0140-6736(07)60669-2.
Results Reference
derived

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A Morbidity-Mortality and Remodeling Study With Valsartan

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