UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003495 |
|---|---|
| Receipt number | R000004011 |
| Scientific Title | The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2010/04/15 |
| Last modified on | 2018/09/21 23:06:09 |
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Basic information
Public title
The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation
Acronym
The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation
Scientific Title
The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation
Scientific Title:Acronym
The study of predictive value of heart rate variability indicators for transplant-related mortality in hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze an impact of heart rate variability indicators on prognosis including transplant-related mortality after allogeneic hematopoietic stem cell transplantation
Basic objectives2
Others
Basic objectives -Others
Prognostic prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The impact of heart rate variability indicators on transplant related mortality after allogeneic hematopoietic stem cell transplantation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are eligible for allogeneic hematopoietic stem cell transplantation and scheduled to undergo allogeneic hematopoietic stem cell transplantation in our hospital
Key exclusion criteria
(1) Difficulty in sticking tape attachments of cardiac sensor for 24-hour ECG monitoring to the skin due to cutaneous lesion or any other condition
(2) The rate of supraventricular or ventricular premature contractions exceed 5 or more percent of total heart beats
(3)Patients with chronic atrial fibrillation
(4)No indication for this study judged by physician in charge
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hino |
Organization
Osaka City University, Graduate School of Medicine
Division name
Hematology
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL
06-6645-3881
hinom@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Nakamae |
Organization
Osaka City University, Graduate School of Medicine
Division name
Hematology(Clinical research center for hematological malignancies )
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL
06-6645-3881
Homepage URL
crc-hematology@med.osaka-cu.ac.jp
Sponsor or person
Institute
Hematology, Osaka City University, Graduate School of Meicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze heart rate variability before conditioning for transplantation and on day 30 after transplantation, and assess an impact on prognosis including transplant-related mortality after allogeneic hematopoietic stem cell transplantation.
Prospective study.
Procedure
Patients undergo the 24-hour ambulatory ECG recording once before conditioning for allogeneic hematopoietic stem cell transplantation and on day 30 after transplantation. The stored ECG data is analyzed by a software for heart rate variability analysis (MemCalc/CHIRAM version 1, Suwatrust, Tokyo, Japan).
Management information
Registered date
| 2010 | Year | 04 | Month | 15 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004011
