Cardiovascular Drugs and Therapy

, Volume 18, Issue 4, pp 305–309 | Cite as

JIKEI HEART Study—A Morbi-Mortality and Remodeling Study with Valsartan in Japanese Patients with Hypertension and Cardiovascular Disease

  • Seibu Mochizuki
  • Mitsuyuki Shimizu
  • Ikuo Taniguchi
  • Kiyoshi Kanae
  • Satoru Yoshida
  • Naoko Tajima
  • Bjorn Dahlöf


Background: Several recent clinical trials have demonstrated that angiotensin II receptor blockers (ARBs) have cardiovascular as well as renal protective effects. Asian patients including Japanese were under-represented in these trials, however, and no large-scale clinical trials of ARBs have yet been performed in Japan. It is therefore important to verify that the results of these studies are also valid for Japanese patients. The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker, in addition to conventional treatment, will improve the prognosis of Japanese patients with cardiovascular diseases (hypertension, ischemic heart disease, congestive heart failure).

Method and Evaluation of Results: Around 3,000 patients with hypertension, ischemic heart disease and/or congestive heart failure will be randomized to receive either additional treatment with valsartan (80 mg/day) or conventional therapy. The follow-up period will be three years. The primary endpoint will be the onset of any cardiovascular event. Secondary endpoints will include death from any cause, changes in left ventricular size and function, renal function, changes in neuro-hormonal levels and quality-of-life assessments. Sub-studies will explore the effect in patients with diabetes mellitus, hyperlipidemia and the effects of combination of drugs.

Conclusion: Improved prognosis would confirm the role of angiotensin II receptor blockers in the treatment of the cardiovascular disease in Japanese patients.

hypertension ischemic heart disease cardiac remodeling heart failure angiotensin II receptor blocker mortality-morbidity 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Bonow RO, Smaha LA, Smith SC Jr, Mensah GA, Lenfant C. World Heart Day 2002: The international burden of cardiovascular disease: Responding to the emerging global epidemic. Circulation 2002;106:1602–1605.Google Scholar
  2. 2.
    Kim S, Iwao H. Molecular and cellular mechanisms of angiotensin II-mediated cardiovascular and renal diseases. Pharmacol Rev 2000;52:11–34.Google Scholar
  3. 3.
    Sadoshima J, Izumo S. The cellular and molecular response of cardiac myocytes to mechanical stress. Annu Rev Physiol 1997;59:551–571.Google Scholar
  4. 4.
    Viberti G, Wheeldon NM. Microalbuminuria reduction with valsartan in patients with Type 2 diabetes mellitus: A blood pressure-independent effect. Circulation 2002;106:672–678.Google Scholar
  5. 5.
    Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001;345:861–869.Google Scholar
  6. 6.
    Parving HH, Lehnert H, Bröchner-Mortensen J, et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001;345:870–878.Google Scholar
  7. 7.
    Cohn JN, Tognoni G. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001;345:1667–1675.Google Scholar
  8. 8.
    Pfeffer MA, McMurray JJ, Velazquez EJ, et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003;349:1893–1906.Google Scholar
  9. 9.
    Dahlöf B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Interven-tion For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002;359:995- 1003.Google Scholar
  10. 10.
    Mann J, Julius S. The valsartan antihypertensive long-term use evaluation (VALUE) trial of cardiovascular events in hypertension. Rationale and design. Blood Press 1998;7:176- 183.Google Scholar
  11. 11.
    Sekikawa A, Horiuchi BY, Edmundowicz D, et al. A “Natural experiment” in cardiovascular epidemiology in the early 21st century. Heart 2003;89:255–257.Google Scholar
  12. 12.
    Hansson L, Hedner T, Dahlöf B. Prospective random-ized open blinded end-point (PROBE) study. A novel design for intervention trials. Blood Press 1992;1:113- 119.Google Scholar
  13. 13.
    Dahlöf B, Devereux RB, Julius S, et al. Characteristics of 9194 patients with left ventricular hypertrophy: The LIFE study. Hypertension 1998;32:989–997.Google Scholar
  14. 14.
    Cohn JN, Tognoni G, Glazer R, Spormann D. Baseline demo-graphics of the Valsartan Heart Failure Trial. Eur J Heart Fail 2000;2:439–446.Google Scholar
  15. 15.
    Kimura M, Mitani H, Isomura Y. [Preclinical and clinical profile of valsartan, a selective angiotensin II type-1 receptor blocker] Nippon Yakurigaku Zasshi 2002;120:353- 360.Google Scholar

Copyright information

© Kluwer Academic Publishers 2004

Authors and Affiliations

  • Seibu Mochizuki
    • 1
  • Mitsuyuki Shimizu
    • 1
  • Ikuo Taniguchi
    • 1
  • Kiyoshi Kanae
    • 1
  • Satoru Yoshida
    • 1
  • Naoko Tajima
    • 2
  • Bjorn Dahlöf
    • 3
  1. 1.Division of Cardiology, Department of Internal MedicineThe Jikei University School of MedicineTokyoJapan
  2. 2.Division of Diabetes, Metabolism and Endocrinology, Department of Internal MedicineThe Jikei University School of MedicineTokyoJapan
  3. 3.Department of MedicineSahlgrenska University Hospital/ÖstraGothenburgSweden

Personalised recommendations