UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045203 |
|---|---|
| Receipt number | R000050830 |
| Scientific Title | Long-term follow-up of patients enrolled in ReRight registry |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2024/08/21 16:26:58 |
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Basic information
Public title
Long-term follow-up of patients enrolled in ReRight registry
Acronym
The ReRight Registry
Scientific Title
Long-term follow-up of patients enrolled in ReRight registry
Scientific Title:Acronym
The ReRight Registry
Region
| Japan |
Condition
Condition
Tricuspid Regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the prevalence of patients with moderate or severe tricuspid regurgitation among the population who underwent transthoracic echocardiography.
To reveal the pathophysiological and morphological features of patients with significant tricuspid regurgitation.
Basic objectives2
Others
Basic objectives -Others
To elucidate the natural course and prognostic determinant factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All cause death, Cardiovascular death, Hospitalization 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
Patients who underwent transthoracic echocardiography and diagnosed as moderate or more than moderate tricuspid regurgitation at the University of Tokyo Hospital, St. Marianna University of Medicine Hospital and Kokura Memorial Hospital from January 2015 to December 2016.
Key exclusion criteria
Patients with congenital heart disease, post tricuspid valve (TV) surgery, post heart transplantation, wearing ventricular assist device, and poor right heart images.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Miura |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
mizumiura-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Miura |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
mizumiura-circ@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic Committee of Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2021 | Year | 08 | Month | 20 | 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
1000
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under analysis
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
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective, observational, multi-center study
Management information
Registered date
| 2021 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050830
