Congestive Heart Failure, Hypertension, Ischemic Heart Disease
Conditions
Keywords
stroke, myocardial infarction, angina, renal damage
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.
Interventions
DRUGvalsartan
Sponsors
Jikei University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| doubling of plasma creatinine (Cr) levels | — |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| death from any cause | — |
Countries
Japan
Outcome results
None listed