A Morbidity-Mortality and Remodeling Study With Valsartan
A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
1 other identifier
interventional
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Jan 2002
Longer than P75 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedOctober 28, 2005
January 1, 2002
August 22, 2005
October 27, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (8)
death from any cause
left ventricular hypertrophy
changes in ECG
proteinuria
B-type natriuretic peptide (BNP)
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure
You may not qualify if:
- Pregnancy
- Severe renal damage
- Severe liver damage
- Acute myocardial infarction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Jikei University School of Medicine
Tokyo, 105-8461, Japan
Related Publications (2)
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.
PMID: 15367828RESULTMochizuki 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.
PMID: 17467513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Seibu Mochizuki, MD., PhD
The Jikei University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 23, 2005
Study Start
January 1, 2002
Study Completion
November 1, 2005
Last Updated
October 28, 2005
Record last verified: 2002-01