Clinical trial NCT00133328: A Morbidity-Mortality and Remodeling Study With Valsartan
Official title: A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Ischemic Heart Disease
Congestive Heart Failure
Keywords: stroke
myocardial infarction
angina
renal damage
Lead sponsor: Jikei University School of Medicine
Sponsor class: OTHER
First posted: 2005-08-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: stroke
measure: new or recurrent transient ischemic attack
measure: new or recurrent acute myocardial infarction
measure: new occurrence or exacerbation of heart failure
measure: new occurrence or exacerbation angina pectoris
measure: dissecting aneurysm of the aorta
measure: lower limb arterial obstruction
measure: transition to dialysis
measure: doubling of plasma creatinine (Cr) levels
Secondary outcomes:
measure: death from any cause
measure: left ventricular hypertrophy
measure: changes in ECG
measure: proteinuria
measure: B-type natriuretic peptide (BNP)
measure: heart failure symptoms
measure: heart failure syndrome (edema, rales on auscultation)
measure: blood pressure and heart rate
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: The Jikei University School of Medicine
Study officials:
affiliation: The Jikei University School of Medicine
name: Seibu Mochizuki, MD., PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.