UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030438 |
|---|---|
| Receipt number | R000034754 |
| Scientific Title | Impact of Frailty in Patients with Severe Functional Tricuspid Regurgitation |
| Date of disclosure of the study information | 2017/12/17 |
| Last modified on | 2021/01/11 17:42:24 |
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Basic information
Public title
Impact of Frailty in Patients with Severe Functional Tricuspid Regurgitation
Acronym
Impact of frailty in FTR
Scientific Title
Impact of Frailty in Patients with Severe Functional Tricuspid Regurgitation
Scientific Title:Acronym
Impact of frailty in FTR
Region
| Japan |
Condition
Condition
Severe Functional Tricuspid Regurgitation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between frailty and prognosis in patients in severe functional TR, and determine whether frailty marker can predict prognosis
Basic objectives2
Others
Basic objectives -Others
Short physical-performance battery (SPPB), frailty index, clinical frailty scale, modified Fried scale, and gait speed are calculated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality(cardiac, non-cardiac), admission due to heart failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria includes patients with severe functional TR undergoing transthoracic echocardiography at the Sakakibara Heart Institute from November 2016.
Key exclusion criteria
Exclusion criteria includes age <20 years, TR with leaflet abnormality (primary TR), <moderate TR, untreated clinically significant coronary artery / valvular / aortic disease requiring interventions, any therapeutic invasive cardiac procedure performed within 6 months of the index procedure, active infections, and currently participating in an investigational drug or another device study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mike Saji |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
Address
3-16-1 Asaahicho, Fuchu, Tokyo, Japan
TEL
042-314-3111
mikesaji8@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mike Saji |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
Address
3-16-1 Asaahicho, Fuchu, Tokyo, Japan
TEL
042-314-3111
Homepage URL
mikesaji8@gmail.com
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Mitsui Life Social Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2017 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 01 | Day |
Other
Other related information
The prospective cohort of patients with severe functional tricuspid regurgitation who are willing to participate in the present study is assembled at the Sakakibara Heart Institute from November 2016. Consecutive patients are approached and invited to complete a comprehensive geriatric evaluation after the consent. The evaluation includes a series of physical performance test and questionnaires focused on frailty. Blood sample is obtained and transthoracic echocardiography is performed. After the enrollment of the present study, trained observers reviews medical records to ascertain adverse events and contact the patients by telephone at 12 months.
Management information
Registered date
| 2017 | Year | 12 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034754
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
