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

Condition	Intervention	Phase
Non-Hodgkin''''s Lymphoma	Drug: Valsartan	Phase IV

Further Study Details: 

Primary Outcomes: Cardiac Event after 3 and 6 course of CHOP(-R)
Secondary Outcomes: Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)
Expected Total Enrollment:  150

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).

Ages Eligible for Study:  15 Years   -   70 Years,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00162955

Hirohisa Nakamae, MD, PhD      +81-6-6645-3881    hirohisa@msic.med.osaka-cu.ac.jp
Masayuki Hino, MD, PhD      +81-6-6645-3881    hinom@med.osaka-cu.ac.jp

Japan
      Graduate School of Medicine, Osaka City University, Osaka,  545-8585,  Japan; Recruiting

Study chairs or principal investigators

Masayuki Hino, MD, PhD,  Study Chair,  Graduate School of Medicine, Osaka City University   
Hirohisa Nakamae, MD, PhD,  Principal Investigator,  Graduate School of Medicine, Osaka City University   

Study ID Numbers:  OLSG-0401
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162955
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13