UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034926 |
|---|---|
| Receipt number | 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 | 2025/11/26 14:38:56 |
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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
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
takahama@ncvc.go.jp
Sponsor or person
Institute
National cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
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
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039637
