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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027411
Receipt No. R000031412
Scientific Title Study of the role of VEGF-A and VEGF-A165b in pathophysiology of pulmonary hypertension
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/19

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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 hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pulmonary hypertension is a very poor prognostic disease that causes pulmonary vascular resistance to rise due to proliferation of endothelial cells of the pulmonary artery, thickening of the media, leading to death from right heart failure. In human severe pulmonary hypertension, such pulmonary artery degeneration progresses, occluded blood vessels appear, and plexiform lesions are seen. It is reported that this plexiform lesion is capillary hyperplasia similar to the glomeruli branched from the trunk of the pulmonary artery at the arteriole level and the expression of mRNA of VEGF and VEGF receptor 2 is enhanced. In addition, it is also known that new blood vessels increase around the occluded blood vessel, and it is reported that the blood VEGF concentration rises in pulmonary hypertension (2). From the above, we believe that there is a high possibility that angiogenesis is involved in the disease state in pulmonary hypertension.
In response to these, this study aims to clarify the role of angiogenesis in pulmonary hypertension by evaluating the ratio of VEGF-A and VEGF-A 165b.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1,All deaths (cardiovascular death / non-cardiovascular death)
2,Exacerbation of pulmonary hypertension
3,If one of the following treatments is required
I) Parenteral administration of prostanoid preparations
Ii) When it is judged that lung transplantation or atrial atrial septation surgery is necessary at clinician's discretion
Key secondary outcomes 1,Circulatory dynamics index (hemodynamic index by right heart catheterization)
2, Subjective symptoms: questionnaire (SF-36)
3,Serum biomarker
4,Cardiac ultrasound examination
5,Respiratory function test
6,Weight loss and discontinuation of home oxygen therapy (HOT)
7,Hospitalization due to occurrence of adverse event other than hospitalization due to pulmonary hypertension
(Hospitalization due to cancer/cerebral infarction/myocardial infarction/left heart failure etc.)

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

Not applicable
Gender Male and Female
Key inclusion criteria 1,pulmonary hypertension
Group 1:pulmonary arterial hypertension (PAH)
Group 2:pulmonary hypertension due to left heart disease
Group 3:pulmonary hypertension associated with pulmonary diseases 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 1,Diagnosis of malignant tumor]
2,Diagnosis of myeloproliferative disorder
3,Diagnosis of inflammatory diseases
4,Patients already using pulmonary vasodilator (prostaglandin I 2 preparation, endothelin receptor antagonist, phosphodiesterase 5 inhibitor, soluble guanylate cyclase stimulant)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Kondo
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Medicine of Cardiopulmonary Disease
Zip code
Address 65, Tsurumaicho, Showa-ku Nagoya-shi, Aichi,Japan
TEL 052-744-0388
Email takahisa@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Kondo
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Medicine of Cardiopulmonary Disease
Zip code
Address 65, Tsurumaicho, Showa-ku Nagoya-shi, Aichi,Japan
TEL 052-744-0388
Homepage URL
Email takahisa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Address
Tel
Email

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
2017 Year 06 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information During definitive diagnosis in cardiac catheterization, a blood test containing VEGF-A, VEGF-A 165 b is performed. In addition, cardiac ultrasonic examination, respiratory function test, vascular endothelial function test, exercise stress test are performed within one month before and after the diagnosis catheter. Evaluate subjective symptom evaluation and physical finding at the same timing. After that, treatment for pulmonary hypertension is started, but various tests including catheter examination are reexamined at 3 months + 1 month after treatment start, and the effect judgment is done. Furthermore, various examination and examination are carried out also in hospitalization due to exacerbation of pulmonary hypertension. Assess the main endpoint as a combined item of total death and exacerbation of pulmonary hypertension and evaluate the relationship between VEGF-A 165 b, VEGF-A 165 b and the ratio of VEGF-A. Furthermore, we evaluate the relationship with secondary evaluation items. As a sub-analysis, we also evaluate the association between changes in hemodynamics, exercise tolerance, vascular endothelial function, respiratory function and the like with VEGF-A 165b.
Also, patients who do not have pulmonary hypertension in outpatient or inpatient treatment at Nagoya University Hospital, and do not have any myeloproliferative disease, infectious disease or cancer, will be treated as control group and compared.

Management information
Registered date
2017 Year 05 Month 19 Day
Last modified on
2017 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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