UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034754