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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Japan1 site

  • The Jikei University School of Medicine

    Tokyo, 105-8461

Other trials in Japan

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.

  1. stroke

  2. new or recurrent transient ischemic attack

  3. new or recurrent acute myocardial infarction

  4. new occurrence or exacerbation of heart failure

  5. new occurrence or exacerbation angina pectoris

  6. dissecting aneurysm of the aorta

  7. lower limb arterial obstruction

  8. transition to dialysis

  9. doubling of plasma creatinine (Cr) levels

Secondary outcomes (8)

  1. death from any cause

  2. left ventricular hypertrophy

  3. changes in ECG

  4. proteinuria

  5. B-type natriuretic peptide (BNP)

  6. heart failure symptoms

  7. heart failure syndrome (edema, rales on auscultation)

  8. 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.

  1. First posted23 Aug 2005 (estimated)
  2. Study startJan 2002
  3. Study completionNov 2005

Resources

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
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 15367828

  • 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.

    PubMed 17467513

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; AzTrials last refreshed its copy on 26 Oct 2026.

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