The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP
Doxorubicin has been one of the most important key drugs in treatment for malignancies.
However, its use is limited by dose-dependent cumulative cardiotoxicity. This multi-centers
trial was designed to investigate the preventive effect of Valsartan, the angiotensin II
type 1 receptor blocker (ARB) on chronic cardiotoxicity due to doxorubicin based
chemotherapy. Patients with untreated non-Hodgkin's lymphoma who are scheduled to receive at
least 6 courses of the standard CHOP (-R) will be randomized by the minimization methods to
the treatment group with Valsartan (80mg once daily by oral during entire 6 courses of CHOP)
or control group. Cardiac function will be evaluated in detail before and after 3 and 6
courses of CHOP (-R).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Cardiac Event after 3rd and 6th course of CHOP(-R)
Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
Masayuki Hino, MD, PhD
Graduate School of Medicine, Osaka City University
Japan: Ministry of Health, Labor and Welfare