UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059870 |
|---|---|
| Receipt number | R000068373 |
| Scientific Title | Prognostic Role of LVGLS in TAVI Patients |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/25 11:00:21 |
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Basic information
Public title
Left Ventricular Strain Versus Ejection Fraction for Risk Stratification Before TAVI: A Comprehensive Meta-Analysis
Acronym
Left Ventricular Strain Versus Ejection Fraction for Risk Stratification Before TAVI: A Comprehensive Meta-Analysis
Scientific Title
Prognostic Role of LVGLS in TAVI Patients
Scientific Title:Acronym
Left Ventricular Strain Versus Ejection Fraction for Risk Stratification Before TAVI: A Comprehensive Meta-Analysis
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Left ventricular global longitudinal strain (LVGLS) is a sensitive marker of subclinical systolic dysfunction in aortic stenosis, where left ventricular ejection fraction (LVEF) often remains preserved despite advanced myocardial impairment. Although several studies have suggested that LVGLS predicts outcomes after transcatheter aortic valve implantation (TAVI), existing evidence has been constrained by modest sample sizes, heterogeneous methods, and inconsistent multivariable adjustment. A comprehensive assessment of the independent prognostic value of LVGLS - directly compared with LVEF - has not been performed. To evaluate the prognostic impact of preprocedural LVGLS on mortality and adverse clinical outcomes after TAVI and to determine whether LVGLS provides greater prognostic discrimination than LVEF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac events and all-cause mortality
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
This study targeted patients who underwent TAVI and examined the preoperative LVGLS and its prognostic predictive ability.
Key exclusion criteria
Studies that did not treat LVGLS as a continuous variable, or studies with overlapping patient populations, were excluded from this research.
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
Saga University
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
CLINICAL RESEARCH CENTER,SAGA UNIVERSITY HOSPITAL
Address
5-1-1 Nabeshima, Saga City, Saga Prefecture
Tel
0952343400
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
| 2025 | Year | 11 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A systematic search of PubMed and Scopus through March 2025 identified studies reporting hazard ratios for pre-procedural LVGLS and post-TAVI outcomes. Random-effects meta-analyses were performed for univariable and multivariable HRs. Prespecified subgroup analyses were conducted by endpoint type, study design, ethnicity, and baseline LVEF. Meta-regression assessed whether mean LVEF modified the GLS-outcome association. Standardized HRs per 1-SD worsening and ratio-of-HRs analyses were used to compare LVGLS with LVEF. Publication bias was evaluated using Egger regression and PET-PEESE.
Management information
Registered date
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068373
