UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042424 |
|---|---|
| Receipt number | R000048431 |
| Scientific Title | Prevalence of Right Ventricular Dysfunction-Pulmonary Hypertension and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis |
| Date of disclosure of the study information | 2020/11/11 |
| Last modified on | 2021/07/17 10:16:25 |
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Basic information
Public title
Prevalence of Right Ventricular Dysfunction-Pulmonary Hypertension and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Acronym
Prevalence of Right Ventricular Dysfunction-Pulmonary Hypertension and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Scientific Title
Prevalence of Right Ventricular Dysfunction-Pulmonary Hypertension and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Scientific Title:Acronym
Prevalence of Right Ventricular Dysfunction-Pulmonary Hypertension and Its Association with COVID-19 Clinical Outcome: A Meta-Analysis
Region
| Asia(except Japan) |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the prevalence of right ventricular dysfunction-pulmonary hypertension AND its association with COVID-19 clinical outcome.
Basic objectives2
Others
Basic objectives -Others
To analyze the prevalence and association of pulmonary hypertension with COVID-19 outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite poor outcome of severity. mortality, need for ICU and mechanical ventilation
Key secondary outcomes
each percentage of primary outcome: severity. mortality, need for ICU and mechanical ventilation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all observational studies or trials that involving adult patients with COVID-19 that had any data of right ventricular dysfunction and pulmonary arterial hypertension for comparison poor vs good outcome
Key exclusion criteria
missing required data, no data on RVD/ PAH, no outcome of interest, other than english language
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Eka |
| Middle name | Prasetya Budi |
| Last name | Mulia |
Organization
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
62-8562765365
eka.prasetya.budi-2017@fk.unair.ac.id
Public contact
Name of contact person
| 1st name | Eka |
| Middle name | Prasetya Budi |
| Last name | Mulia |
Organization
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
628562765365
Homepage URL
https://www.researchgate.net/profile/Eka_Mulia
eka.prasetya.budi-2017@fk.unair.ac.id
Sponsor or person
Institute
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komite Etik Penelitian Kesehatan RSUD Dr Soetomo, Surabaya, Indonesia
Address
Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel
0315501011
kontak@rsudrsoetomo.jatimprov.go.id
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
| 2020 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.5114/aoms/136342
Number of participants that the trial has enrolled
1728
Results
Pooled prevalence of RVD in COVID-19 was 19% and PH was 22%. RVD and PH was associated with increased mortality, severity , ICU admission, and mechanical ventilation.
Results date posted
| 2021 | Year | 01 | Month | 05 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
A systematic search of all observational studies or trials that involving adult patients with COVID-19 that had any data of RVD and PAH for comparison of poor vs good outcome was carried out using the PubMed, Science Direct, Scopus, ProQuest, and MedRxiv databases.
Management information
Registered date
| 2020 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048431
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