UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055452 |
|---|---|
| Receipt number | R000063365 |
| Scientific Title | Prognostic value of right ventricular free-wall longitudinal strain in tricuspid regurgitation: a meta-analysis |
| Date of disclosure of the study information | 2024/09/07 |
| Last modified on | 2026/03/10 09:17:22 |
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Basic information
Public title
Prognostic value of right ventricular free-wall longitudinal strain in tricuspid regurgitation: a meta-analysis
Acronym
Usefulness of right ventricular strain in tricuspid regurgitation
Scientific Title
Prognostic value of right ventricular free-wall longitudinal strain in tricuspid regurgitation: a meta-analysis
Scientific Title:Acronym
Usefulness of right ventricular strain in tricuspid regurgitation
Region
| Japan |
Condition
Condition
tricuspid regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tricuspid valve regurgitation is a poor prognostic indicator of right heart failure. Evaluation of right ventricular function indices is important for prognosis, but it is unclear which right ventricular function indices are most prognostic. The purpose of this study was to compare the prognostic value of right ventricular function indices obtained by echocardiography.
Basic objectives2
Others
Basic objectives -Others
Usefulness of the echocardiographic measurements
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prognostic value of right ventricular free-wall longitudinal strain
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A paper examining the prognosis of tricuspid regurgitation and analyzing the prognostic value of echocardiographic indices, including right ventricular free-wall longitudinal strain.
Key exclusion criteria
Papers that do not describe hazard ratios for right ventricular free-wall longitudinal strain at continuous values
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nabeshima |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
TEL
0952-31-6511
y.nabeshima1016@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nabeshima |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
TEL
0952-31-6511
Homepage URL
y.nabeshima1016@gmail.com
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Saga University
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
Clinincal Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
| 2024 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12574-025-00715-w
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12574-025-00715-w
Number of participants that the trial has enrolled
4039
Results
Of 4,288 publications, 11 studies involving 12 patient cohorts were included for analysis. Mean age was 71 years, with follow-up periods ranging from 18 to 60 months. RVfwLS was associated with outcome (HR: 1.09, 95% confidence interval: 1.07-1.12). RVfwLS provided greater prognostic value than sPAP, RVFAC, and LVEF.
Results date posted
| 2026 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age was 72.5 years, and follow-up duration ranged from 18 to 60 months. TR was often severe. As for the etiology of TR, six studies only included functional TR, while the remaining five studies included both functional TR and primary TR. The primary endpoint was all-cause mortality in 8 studies, and four other studies used a composite endpoint. Echocardiographic baseline characteristics were extracted, with a focus on pulmonary or RV function (SPAP, TAPSE, RVFAC, RVfwLS).
Participant flow
not applicable
Adverse events
not applicable
Outcome measures
All cause death or MACE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the prognostic value of right ventricular function indices with other parameters in tricuspid regurgitation, with right ventricular free-wall longitudinal strain as the axis.
Management information
Registered date
| 2024 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063365
