Prevention of CHOP-induced Chronic Cardiotoxicity

This study has been completed.
Sponsor:
Information provided by:
Osaka City University
ClinicalTrials.gov Identifier:
NCT00162955
First received: September 9, 2005
Last updated: May 7, 2012
Last verified: September 2010

September 9, 2005
May 7, 2012
May 2004
September 2010   (final data collection date for primary outcome measure)
Cardiac Event after 3rd and 6th course of CHOP(-R) [ Time Frame: Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R). ] [ Designated as safety issue: No ]
Cardiac Event after 3 and 6 course of CHOP(-R)
Complete list of historical versions of study NCT00162955 on ClinicalTrials.gov Archive Site
Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R) [ Time Frame: 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R). ] [ Designated as safety issue: No ]
Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)
Not Provided
Not Provided
 
Prevention of CHOP-induced Chronic Cardiotoxicity
The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP

The purpose of this study is 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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Non-Hodgkin's Lymphoma
Drug: Valsartan
Patients allocated into ARB administration group take Valsartan (80mg/day) from the day of the start of 1st CHOP until the completion of all the evaluations.
Other Name: Diovan
  • Experimental: ARB administration
    80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations
    Intervention: Drug: Valsartan
  • No Intervention: non-administration
    ARB non-administration group
Toko H, Oka T, Zou Y, Sakamoto M, Mizukami M, Sano M, Yamamoto R, Sugaya T, Komuro I. Angiotensin II type 1a receptor mediates doxorubicin-induced cardiomyopathy. Hypertens Res. 2002 Jul;25(4):597-603.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00162955
OLSG-0401
Yes
Hirohisa Nakamae, MD. PhD., Osaka City University
Osaka City University
Not Provided
Study Chair: Masayuki Hino, MD, PhD Graduate School of Medicine, Osaka City University
Principal Investigator: Hirohisa Nakamae, MD, PhD Graduate School of Medicine, Osaka City University
Osaka City University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP