UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036284 |
|---|---|
| Receipt number | R000041329 |
| Scientific Title | Investigation about clinical impact of frailty on patients who underwent ICD/CRT implantation |
| Date of disclosure of the study information | 2019/03/24 |
| Last modified on | 2022/09/26 18:10:10 |
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Basic information
Public title
Investigation about clinical impact of frailty on patients who underwent ICD/CRT implantation
Acronym
Frailty Device Registry
Scientific Title
Investigation about clinical impact of frailty on patients who underwent ICD/CRT implantation
Scientific Title:Acronym
Frailty Device Registry
Region
| Japan |
Condition
Condition
ventricular tachycardia, ventricular fibrillation, chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an association between frailty / sarcopenia and procedural related complications / prognosis in patients who undergo ICD / CRT implantation.
Basic objectives2
Others
Basic objectives -Others
investigation for risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
composite endpoint of heart failure hospitalization and death
Key secondary outcomes
procedural related complications
appropriate ICD therapy including anti-tachycardia pacing and cardio-version
heart failure hospitalization
all cause death
cardiovascular death
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
cases with frailty / sarcopenia
Interventions/Control_2
cases without frailty / sarcopenia
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. ICD or CRT are going to be implanted due to ventricular tachyarrhythmia and chronic heart failure
2. The cases who give written informed consent
Key exclusion criteria
1. the cases in whom principal investigator or co-investigators judge unsuitable to include.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Naruse |
Organization
Hamamatasu University School of Medicine
Division name
Division of Cardiology, Internal Medicine III
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL
0534352356
ynaruse@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Naruse |
Organization
Hamamatasu University School of Medicine
Division name
Division of Cardiology, Internal Medicine III
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL
0534352356
Homepage URL
ynaruse@hama-med.ac.jp
Sponsor or person
Institute
Hamamatasu University School of Medicine, Division of Cardiology, Internal Medicine III
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatasu University School of Medicine, IRB
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
Tel
0534352680
rinri@hama-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 24 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 24 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041329
