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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036284
Receipt No. 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 2019/09/23

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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
18 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 900

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
Email 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
Email ynaruse@hama-med.ac.jp

Sponsor
Institute Hamamatasu University School of Medicine, Division of Cardiology, Internal Medicine III
Institute
Department

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
Email 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
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 Open public 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
2023 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
2019 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041329

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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