NCT00162955

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 8, 2012

Status Verified

September 1, 2010

Enrollment Period

6.3 years

First QC Date

September 9, 2005

Last Update Submit

May 7, 2012

Conditions

Non-Hodgkin's Lymphoma

Keywords

untreated adult Non-Hodgkin's LymphomaCHOP protocolAngiotensin II Type 1 Receptor BlockersCardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • 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).

Study Arms (2)

ARB administration

EXPERIMENTAL

80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations

Drug: Valsartan

non-administration

NO INTERVENTION

ARB non-administration group

Interventions

ValsartanDRUG

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.

Also known as: Diovan
ARB administration

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Medicine, Osaka City University

Osaka, Osaka, 545-8585, Japan

Location

Related Publications (1)

  • 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.

    PMID: 12358147BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-HodgkinCardiomyopathies

Interventions

Valsartan

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

May 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 8, 2012

Record last verified: 2010-09

Locations

JP(1)