UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032723 |
|---|---|
| Receipt number | R000037316 |
| Scientific Title | Study of the role of VEGF-A and VEGF-A165b in pathophysiology of pulmonary hypertension |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2023/11/28 23:07:26 |
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Basic information
Public title
Study of the role of VEGF-A and VEGF-A165b in pathophysiology of pulmonary hypertension
Acronym
Study of the role of VEGF-A and VEGF-A165b in pathophysiology of pulmonary hypertension
Scientific Title
Study of the role of VEGF-A and VEGF-A165b in pathophysiology of pulmonary hypertension
Scientific Title:Acronym
Study of the role of VEGF-A and VEGF-A165b in pathophysiology of pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary artery hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, clarify the role of angiogenesis in pulmonary hypertension by evaluating the ratio of VEGF-A to VEGF-A 165 b
Basic objectives2
Others
Basic objectives -Others
the same above
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
circulating plasma VEGF-A,VEGF-A165b
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Patients satisfying the criteria for diagnosis of pulmonary hypertension by right heart catheter examination from August 1, 2015 to March 31, 2018, and satisfying the following conditions
1.pulmonary hypertension
Group 1:pulmonary arterial pulmonary hypertension(PAH)
Group 2:pulmonary hypertension due to left heart disease
Group 3:pulmonary hypertension associated with pulmonary disease and/or hypoxia
Group 4:Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Group 5:pulmonary hypertension accompanied by unknown multifactorial mechanism
2.Men and women aged 16 years or older
3.WHO function classification 2 or more
Key exclusion criteria
Diagnosis of malignant tumor
Those already using pulmonary vasodilator (prostaglandin I 2 preparation, endothelin receptor antagonist, phosphodiesterase 5 inhibitor, stimulant of soluble guanylate cyclase)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Kondo |
Organization
Nagoya University
Division name
Department of Advandced in Cardiopulmonary Disease
Zip code
4640814
Address
Tsurumai 65 , Syouwaku, Nagoya, Aichi, Japan
TEL
052-744-0388
takahisa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University
Division name
Department of Advandced in Cardiopulmonary Disease
Zip code
4640814
Address
Tsurumai 65 , Syouwaku, Nagoya, Aichi, Japan
TEL
052-744-0388
Homepage URL
bontenyama@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Universiy
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagoya University
Address
Tsurumai 65 , Syouwaku, Nagoya, Aichi, Japan
Tel
052-744-0388
unknown
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
| 2018 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circrep/3/3/3_CR-20-0096/_html/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circrep/3/3/3_CR-20-0096/_html/-char/en
Number of participants that the trial has enrolled
50
Results
sVEGF-A165b has the potential to detect LD-PH among the etiologies of PH, and sES may detect CTD-PAH in PAH. In addition, sES may be a marker to estimate the severity of PH. Because sES was correlated with the main items of the ESC risk table, sES is thought to reflect the severity of PH in recent treatment strategies. Further studies are needed in a treatment-naive cohort to verify the usefulness of sES.
Results date posted
| 2020 | Year | 05 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
For writing a pape
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 10 | Day |
Baseline Characteristics
Of the 107 PH patients, 48 (44.9%) were in Group 1, 5 (4.7%) were in Group 2, 4 (3.7%) were in Group 3, and 50 (46.7%) were in Group 4. There were significant differences among the groups in terms of age, sex, and plasma hemoglobin concentrations; 85% and 58% of patients in Groups 1 and 4, respectively, were female. Hemoglobin levels were significantly higher in Group 3 than in the other groups. With regard to hemodynamics, there were significant differences among the groups in diastolic pulmonary pressure (dPAP), cardiac index (CI), mean right pressure (mRAP), and PAWP. dPAP and CI were significantly higher in Group 1, and mRAP was significantly lower in Group 3. There were no significant differences in the other indicators among the groups.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037316
