UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005066
Receipt number R000006016
Scientific Title Impact of angiotensin II receptor antagoniston on adriamycin-induced cardiomyopathy
Date of disclosure of the study information 2011/04/01
Last modified on 2016/02/10 16:28:29

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Basic information

Public title

Impact of angiotensin II receptor antagoniston on adriamycin-induced cardiomyopathy

Acronym

Impact of ARB on adriamycin-induced cardiomyopathy

Scientific Title

Impact of angiotensin II receptor antagoniston on adriamycin-induced cardiomyopathy

Scientific Title:Acronym

Impact of ARB on adriamycin-induced cardiomyopathy

Region

Japan


Condition

Condition

Marignancy patients who will treat with adriamycin

Classification by specialty

Cardiology Hematology and clinical oncology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of ARB on cardiac nfunction of malignancy patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Systolic and diastolic function by means of echocardiography

Key secondary outcomes

Regional left ventricular myocrdial function by menas of speckle-trakicng method.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

angiotensin II receptor antagonist(olmesartan)

Interventions/Control_2

no medication (olmesartan)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Malignancy patients who will treat with adrimycin

Key exclusion criteria

1. Patients with obstructive hypetorophic cardiomyopathy 2. Allergy of ARB 3. Patients with pregnancy or likelihood of pregnancy 4. Patients with bilateralrenal artery stenosis 5. Patients receiving ARB

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidekazu Tanaka

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code


Address

7-5-2, Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-5846

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hidekazu Tanaka

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine, Department of Internal Medicine

Zip code


Address


TEL

078-382-5846

Homepage URL


Email



Sponsor or person

Institute

Division of Cardiovascular Medicine, Department of Internal Medicine,
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Cardiovascular Medicine, Department of Internal Medicine,
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2011 Year 02 Month 14 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 02 Month 10 Day

Last modified on

2016 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006016


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name