Clinical trial · Interventional
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
NCT00162955CI-TRIAL-00006870completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valsartan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARB administration
- description
- 80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations
- interventionNames
- Drug: Valsartan
- type
- NO_INTERVENTION
- label
- non-administration
- description
- ARB non-administration group
Primary outcomes (1)
- measure
- Cardiac Event after 3rd and 6th course of CHOP(-R)
- timeFrame
- Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDToko 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. PMID 12358147