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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030438
Receipt No. 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 2018/12/23

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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
Email 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
Email mikesaji8@gmail.com

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034754

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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