UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052679 |
|---|---|
| Receipt number | R000060116 |
| Scientific Title | Prognostic Value of Right Ventricular Free-Wall Longitudinal Strain in Patients with Pulmonary Hypertension: Systematic Review and Meta-Analyses |
| Date of disclosure of the study information | 2023/11/02 |
| Last modified on | 2025/11/25 10:50:52 |
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Basic information
Public title
Prognostic Value of Right Ventricular Function Indices by Echocardiography in Patients with Pulmonary Hypertension: Systematic Review and Meta-Analysis
Acronym
Prognostic Value of RV Function Parameteres in PH Patients
Scientific Title
Prognostic Value of Right Ventricular Free-Wall Longitudinal Strain in Patients with Pulmonary Hypertension: Systematic Review and Meta-Analyses
Scientific Title:Acronym
Prognostic Value of RVfwLS in Patients with PH
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although echocardiographic paramters of right ventricular function are known to be associated with prognosis in patients with pulmonary hypertension, there are no reviews comparing the usefulness of each parameter. Accordingly, we conducted a systematic review and performed a meta-analysis to examine the prognostic value of right ventricular freer-wall longitudinal strain in patients with pulmonary hypertension and directly compared it with those of other right ventricular function and hemodynamic parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Both all-cause death and composite endpoint
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
Inclusion criteria were as follows: (1) full-text papers in peer-reviewed journals, (2) studies reporting the mean and standard deviation of RVfwLS by 2DE speckle tracking analysis, (3) studies that reported outcomes of all-cause mortality or a composite endpoint, including cardiopulmonary events and death, and (4) studies reporting the hazard ratio of RVfwLS using uni- or multi-variable Cox proportional hazard analysis.
Key exclusion criteria
Studies involving children and articles not in English were excluded.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nabeshima |
Organization
Faculty of Medicine, Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952-31-6511
y.nabeshima1016@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nabeshima |
Organization
Faculty of Medicine, Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952-31-6511
Homepage URL
y.nabeshima1016@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
None
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
Saga University Clinical Research Review Board
Address
5-1-1 Nabeshima, Saga, Japan
Tel
0952-34-3357
crb@mail.admin.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
| 2023 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
https://openheart.bmj.com/content/11/1/e002561
Publication of results
Unpublished
Result
URL related to results and publications
https://openheart.bmj.com/content/11/1/e002561
Number of participants that the trial has enrolled
2790
Results
The pooled HR of a 1 SD decrease of RVfwLS was 1.80, and there was a significant association with all-cause death and composite endpoints. The ratio of HR analysis revealed that RVfwLS has a significant, strong association with all-cause death and cardiac events per 1 SD change, compared with corresponding values of SPAP, sTV, RVFAC or TAPSE. RVfwLS was a significant prognostic factor regardless of the aetiology of PH.
Results date posted
| 2025 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 4048 articles retrieved from three databases, 20 articles and 21 patient groups with 2790 subjects were finally included in this meta-analysis. The pooled mean value of RVfwLS was 17.0%, reflecting impaired RV systolic function. Five studies included only WHO group 1 PH, and one study included only group 2 PH. The remaining studies involved patients with various types of PH. The primary endpoint was all-cause mortality in 9 studies, and 11 other studies used a composite endpoint. Follow-up duration ranged from 13 to 77.7 months. Of the 20 articles, SPAP, s'-TV, FAC and TAPSE were reported in 10, 4, 12 and 14 studies, respectively. Seventeen studies reported results of univariable analysis, and three studies reported results of multivariable analysis after adjusting several covariates.
Participant flow
Not applicable.
Adverse events
Not applicable.
Outcome measures
HRs were standardised using the within-study SD. The ratio of HRs of a 1 SD change in RVfwLS versus systolic pulmonary arterial pressure, systolic tricuspid annular velocities, RV fractional area change or tricuspid annular plane systolic excursion was calculated for each study, after which we conducted a random model meta-analysis. Subgroup analysis regarding the type of outcome, aetiology of PH and software vendor was also performed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will search for articles presenting the hazard ratio (HR) of two-dimensional right ventricular free-wall longitudinal strain (RVfwLS) in pulmonary hypertension (PH). HRs will be standardized using the within-study standard deviation (SD). The ratio of HRs of a 1SD change in RVfwLS versus systolic pulmonary arterial pressure, systolic tricuspid annular velocities, RV fractional area change, or tricuspid annular plane systolic excursion will be calculated for each study, after which we conducted a random-model meta-analysis. Subgroup analysis regarding the type of outcome, etiology of PH, and software vendor will also be performed.
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060116
