A Morbidity-Mortality and Remodeling Study With Valsartan
October 27, 2005 updated by: Jikei University School of Medicine
A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Enrollment
3000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan, 105-8461
- The Jikei University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
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
Outcome Measure |
|---|
|
blood pressure and heart rate
|
|
proteinuria
|
|
death from any cause
|
|
left ventricular hypertrophy
|
|
changes in ECG
|
|
B-type natriuretic peptide (BNP)
|
|
heart failure symptoms
|
|
heart failure syndrome (edema, rales on auscultation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Seibu Mochizuki, MD., PhD, The Jikei University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (Estimate)
August 23, 2005
Study Record Updates
Last Update Posted (Estimate)
October 28, 2005
Last Update Submitted That Met QC Criteria
October 27, 2005
Last Verified
January 1, 2002
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Heart Failure
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Hypertension
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Valsartan
Other Study ID Numbers
- JHS2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.