Status:
COMPLETED
Prevention of CHOP-induced Chronic Cardiotoxicity
Lead Sponsor:
Osaka City University
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
15-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00162955
Start Date
May 1 2004
End Date
September 1 2010
Last Update
May 8 2012
Active Locations (1)
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1
Graduate School of Medicine, Osaka City University
Osaka, Osaka, Japan, 545-8585