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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016778
Receipt No. R000019291
Scientific Title Exercise measures of systolic and diastolic function in patients with history of chemotherapy
Date of disclosure of the study information 2015/03/11
Last modified on 2018/03/14

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Basic information
Public title Exercise measures of systolic and diastolic function in patients with history of chemotherapy
Acronym Exercise measures of systolic and diastolic function in patients with history of chemotherapy
Scientific Title Exercise measures of systolic and diastolic function in patients with history of chemotherapy
Scientific Title:Acronym Exercise measures of systolic and diastolic function in patients with history of chemotherapy
Region
Japan

Condition
Condition Patients without apparent heart failure with a history of chemotherapy
Classification by specialty
Medicine in general Cardiology Hematology and clinical oncology
Pediatrics Adult Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the mechanism of reduced cardiac function in patients with a history of chemotherapy by evaluating their cardiac function with exercise echocardiography and cardiopulmonary exercise testing.
Basic objectives2 Others
Basic objectives -Others Conduct a leading-edge assessment procedure by measuring intraventricular pressure difference.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Longitudinal and circumferential strain, torsional motion, volumetric change of LV and RV, intraventricular pressure difference of LV and RV, maximal oxygen consumption, anaerobic metabolic threshold
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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
Maneuver
Interventions/Control_1 Perform an exercise echocardiography and/or cardiopulmonary exercise test to patients with the history of chemotherapy.
Interventions/Control_2 Perform an exercise echocardiography and/or cardiopulmonary exercise test to control patients.
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
10 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Patients with the history of chemotherapy (especially anthracycline antibiotics)
Key exclusion criteria Patients with severe heart failure symptoms.
Patients with low EF (40%>), and/or low SpO2(85%>).
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Takahashi
Organization Juntendo University Faculty of Medicine
Division name Department of Pediatrics
Zip code
Address 2-1-1 Hongo, Bunkyo-ku
TEL 03-3813-3111
Email kentaka@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayumi Ifuku
Organization Juntendo University Faculty of Medicine
Division name Department of Pediatrics
Zip code
Address 2-1-1 Hongo, Bunkyo-ku
TEL 03-3813-3111
Homepage URL
Email myifuku@juntendo.ac.jp

Sponsor
Institute Ken Takahashi
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2015 Year 03 Month 11 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 Preinitiation
Date of protocol fixation
2015 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 11 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
2015 Year 03 Month 11 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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