UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016778 |
|---|---|
| Receipt number | 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 13:22:09 |
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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
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
myifuku@juntendo.ac.jp
Sponsor or person
Institute
Ken Takahashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019291
