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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034926
Receipt No. R000039637
Scientific Title A registry for patients with tricuspid regurgitation (TR): single center prospective observational cohort study.
Date of disclosure of the study information 2018/11/19
Last modified on 2019/01/03

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Basic information
Public title A registry for patients with tricuspid regurgitation (TR): single center prospective observational cohort study.
Acronym TR registry
Scientific Title A registry for patients with tricuspid regurgitation (TR): single center prospective observational cohort study.
Scientific Title:Acronym TR registry
Region
Japan

Condition
Condition Tricuspid regurgitation
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate epidemiology of tricuspid regurgitation (TR), relationships between TR and clinical features (severity of heart failure, cardiac structure and function, and long-term clinical outcomes), especially to understand clinical prognostic factors.
Basic objectives2 Others
Basic objectives -Others 1.Long-term clinical outcomes in patients with TR
2. Prognostic factors in TR patients
3. Differences in clinical background between patients with improved severity of TR and those with unchanged severity of TR, and clinical outcomes in the two groups.
4. Association of clinical background (underlying etiology) with long-term prognosis in the enrolled patients.

5. Relationships ofcardiac structure and function with long-term prognosis in the enrolled patients
6. Relationships of heart failure severity with severity of liver dysfunction in the enrolled patients
7. Relationships of heart failure severity with severity of renal dysfunction in the enrolled patients

Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationships between each clinical parameter and composite end point in the enrolled patients with TR (All-cause mortality or heart failure admission)
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 1. Patients (over 20 years old) with 3-4 or 4 degrees of TR in echocardiography
2. Patients who are able to provide written informed consent
Key exclusion criteria Patients with active infectious endocarditis
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chisato Izumi
Organization National cerebral and Cardiovascular Center
Division name Department of cardiovascular medicine
Zip code
Address Fujishirodai, 5-7-1, Suita
TEL 06-6833-5012
Email izumi-ch@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takahama
Organization National cerebral and Cardiovascular Center
Division name Department of cardiovascular medicine
Zip code
Address Fujishirodai, 5-7-1, Suita
TEL 06-6833-5012
Homepage URL
Email takahama@ncvc.go.jp

Sponsor
Institute National cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 11 Month 19 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
2018 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 11 Month 18 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039637

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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