Prevention of CHOP-induced Chronic Cardiotoxicity

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osaka City University
• Treatments: Angiotensin II Type 1 Receptor Blockers; Valsartan

Criteria

Inclusion Criteria:

• Clinical diagnosis of non-Hodgkin's lymphoma (NHL)

• Untreated lymphoma

• Performance status from 0 to 1,

• Total serum bilirubin < 2.0 mg/dl

• Serum creatinine level < 2.0 mg/dl

• Ejection fraction of the left ventricle >50 %

• Systolic blood pressure at rest being 90 mmHg or more

Exclusion Criteria:

• Severe complication including chronic or acute heart failure, angina, old myocardial infarction, liver cirrhosis, and interstitial pneumonia

• Pregnancy, nursing mothers or women of child-bearing potential

• Hypertension under medication

• Diabetes mellitus under medication

• Hyperthyroidism, nephrotic syndrome, Cushing's syndrome

• Atrial arrythmias

• Severe psychopathy

• Cerebrovascular accidents within the past 3 months

• Positive serum HBs antigen or HCV antibody

• A history of renal failure

• A contraindication to A-II antagonists or noncompliance

• Treatment with any of the following drugs within the past 3 months : A-II antagonists, ACE inhibitors, vitamin E, probucol, calcium antagonists, beta-blockers, and steroid pulse therapy.