UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037762 |
|---|---|
| Receipt number | R000043066 |
| Scientific Title | Observational study of sarcopenia in patients with a ventricular assist device implantation for heart failure |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2020/02/21 09:24:33 |
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Basic information
Public title
Observational study of sarcopenia in patients with a ventricular assist device implantation for heart failure
Acronym
Observational study of sarcopenia in patients with a ventricular assist device implantation for heart failure
Scientific Title
Observational study of sarcopenia in patients with a ventricular assist device implantation for heart failure
Scientific Title:Acronym
Observational study of sarcopenia in patients with a ventricular assist device implantation for heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of sarcopenia on clinical outcomes in patients implanted with ventricular assist device for heart failure
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality
Key secondary outcomes
Cerebrovascular accident, major bleeding, major infection
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ventricular assist device implantation in National Cerebral and Cardiovascular Center.
Key exclusion criteria
Patients who denied study entry.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Norihide |
| Middle name | |
| Last name | Fukushima |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Transplant Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka, Japan 564-0018
TEL
06-6170-1070
nori@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Iwasaki |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Transplant Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka, Japan 564-0018
TEL
06-6170-1070
Homepage URL
http://www.ncvc.go.jp/hospital/pub/clinical-research/untersuchung/post_221.html
kiwasaki@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center, Department of Transplant Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of National Cerebral and Cardiovascular Center
Address
Kishibe-Shinmachi, Suita, Osaka, Japan 564-0018
Tel
06-6170-1070
rec-office-ac@ncvc.go.jp
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
国立循環器病研究センター（大阪府）
National Cerebral and Cardiovascular Center (Osaka)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 22 | 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
147
Results
In the low CER index groups, mortality and intracranial hemorrhage after CF-iLVAD implantation were significantly more frequent than in high CER index groups (12.3% vs 1.4%, P<0.01 and 23.3% vs 8.1%, P=0.01,). Multivariate Cox proportional hazard models revealed that a low CER index was an independent predictor of intracranial hemorrhage in patients receiving CF-iLVAD (hazard ratio: 3.63; 95% confidence interval: 1.43-9.24; P<0.01).
Results date posted
| 2020 | Year | 02 | Month | 21 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
An article including the study results is under submission.
Date of the first journal publication of results
Baseline Characteristics
mean age 43.7+-12.5 yr, 106 male
Participant flow
We retrospectively reviewed 147 patients ) who underwent CF-iLVAD implantation between April 2011 and June 2019.
Adverse events
Over a median interquartile range (IQR) follow-up of 2.3 yr, there were 10 (6.8%) deaths and 43 (29.3%) cerebrovascular events.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
This study evaluates the relationship between sarcopenia and clinical outcomes (mortality, cerebrovascular accident, major bleeding and major infection)
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043066
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