A Morbidity-Mortality and Remodeling Study With Valsartan

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary stroke
Primary new or recurrent transient ischemic attack
Primary new or recurrent acute myocardial infarction
Primary new occurrence or exacerbation of heart failure
Primary new occurrence or exacerbation angina pectoris
Primary dissecting aneurysm of the aorta
Primary lower limb arterial obstruction
Primary transition to dialysis
Primary doubling of plasma creatinine (Cr) levels
Secondary death from any cause
Secondary left ventricular hypertrophy
Secondary changes in ECG
Secondary proteinuria
Secondary B-type natriuretic peptide (BNP)
Secondary heart failure symptoms
Secondary heart failure syndrome (edema, rales on auscultation)
Secondary blood pressure and heart rate

Sponsors