A Morbidity-Mortality and Remodeling Study With Valsartan
- Conditions
- HypertensionIschemic Heart DiseaseCongestive Heart Failure
- Registration Number
- NCT00133328
- Lead Sponsor
- Jikei University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure
- Pregnancy
- Severe renal damage
- Severe liver damage
- Acute myocardial infarction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method blood pressure and heart rate 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)
Trial Locations
- Locations (1)
The Jikei University School of Medicine
🇯🇵Tokyo, Japan