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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
