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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARB administration | Experimental | 80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations |
|
| non-administration | No Intervention | ARB non-administration group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R) | 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masayuki Hino, MD, PhD | Graduate School of Medicine, Osaka City University | Study Chair |
| Hirohisa Nakamae, MD, PhD | Graduate School of Medicine, Osaka City University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graduate School of Medicine, Osaka City University | Osaka | Osaka | 545-8585 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12358147 | Background | 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. doi: 10.1291/hypres.25.597. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |