HypertensionPhase 4NCT00133328
A Morbidity-Mortality and Remodeling Study With Valsartan
A Phase 4 study testing valsartan in people with Hypertension and Ischemic Heart Disease, run by Jikei University School of Medicine at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypertension, Ischemic Heart Disease, Congestive Heart Failure
- What is being tested?
- valsartan
- How many people
- 3,000 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2002to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure
Who cannot join
- Pregnancy
- Severe renal damage
- Severe liver damage
- Acute myocardial infarction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- valsartan
- Keywords
- stroke, myocardial infarction, angina, renal damage
- Medical subject headings
- Hypertension, Myocardial Ischemia, Heart Failure, Stroke, Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
heart failure symptoms
heart failure syndrome (edema, rales on auscultation)
blood pressure and heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startJan 2002
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants
Sponsor and investigators
- Lead sponsor
- Jikei University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Seibu Mochizuki, MD., PhD, Study chair, The Jikei University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133328
- Sponsor's protocol ID
- JHS2002
- Status last verified
- Jan 2002
- First submitted
- 22 Aug 2005
- Last updated
- 28 Oct 2005
- Results posted
- No
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.
PubMed 15367828Mochizuki 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.
PubMed 17467513
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00133328
- Acronym / sponsor ID
- JHS2002
- Keywords
- stroke, myocardial infarction, angina, renal damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants
- Lead sponsor
- Jikei University School of MedicineUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Nov 2005
- First posted
- 23 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure
Key exclusion criteria (4 listed)
- Pregnancy
- Severe renal damage
- Severe liver damage
- Acute myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsartan | Drug | – |
Primary outcome
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
8 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2005.
- Results publication: PubMed 15367828Mochizuki 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.
- Derived from this study: PubMed 17467513Mochizuki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seibu Mochizuki, MD., PhD study chair
The Jikei University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan in people with Hypertension and Ischemic Heart Disease, run by Jikei University School of Medicine at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke. The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2005.