UMIN-CTR Clinical Trial

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

pulmonary hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Takahisa
Middle name
Last name	Kondo

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Advanced Medicine of Cardiopulmonary Disease

Zip code

4668560

Address

65, Tsurumaicho, Showa-ku Nagoya-shi, Aichi,Japan

TEL

052-744-0388

Email

takahisa@med.nagoya-u.ac.jp

Name of contact person

1st name	Takahisa
Middle name
Last name	Kondo

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Advanced Medicine of Cardiopulmonary Disease

Zip code

4668560

Address

65, Tsurumaicho, Showa-ku Nagoya-shi, Aichi,Japan

TEL

052-744-0388

Homepage URL

Email

takahisa@med.nagoya-u.ac.jp

Institute

Nagoya University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagoya University

Address

65, Tsurumaicho, Showa-ku Nagoya-shi, Aichi,Japan

Tel

052-744-0388

Email

takahisa@med.nagoya-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

01

Day

URL releasing protocol

https://www.jstage.jst.go.jp/article/circrep/3/3/3_CR-20-0096/_html/-char/en

Publication of results

Unpublished

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

0

Results

unpublishied

Results date posted

2023

Year

11

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

unpublished

Participant flow

unpublished

Adverse events

unpublished

Outcome measures

unpublished

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2017

Year

05

Month

16

Day

Date of IRB

2017

Year

05

Month

16

Day

Anticipated trial start date

2017

Year

05

Month

22

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 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.

Registered date

2017

Year

05

Month

19

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=R000031412