UMIN-CTR Clinical Trial

Public title

Investigation of relationship between the pathogenesis of pulmonary hypertension and dysbiosis

Acronym

Pulmonary hypertension and dysbiosis

Scientific Title

Investigation of relationship between the pathogenesis of pulmonary hypertension and dysbiosis

Scientific Title:Acronym

Pulmonary hypertension and dysbiosis

Region

Japan

Condition

Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hyperetension

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

It was considered that the pathogenesis of pulmonary arterial hypertension (PAH) and chronic thromboemblic pulmonary hypertension (CTEPH) could be associated with systemic inflammation. However, the focus of systemic inflammation has been unclear. The purpose of this study is to investigate the association between the alternation of intestinal flora and the severity of these pulmonary hypertensive disease.

Basic objectives2

Others

Basic objectives -Others

This is an observation study. The association between composition of intestinal flora and hemodynamics of PAH or CTEPH patients

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Following endpoints were evaluated at diagnosis, 6, 12,24,36 months after starting treatments.

1) The composition of intestinal flora by 16S rRNA analysis
2) Functional analysis by meta-genome analysis

Key secondary outcomes

Following endpoints were evaluated at diagnosis, 6, 12,24,36 months after starting treatments.

1) Right heart categorization
2) echocardiography
3) blood examination (BNP, UA, CRP)
4) fecal biochemistry (butyric acid, lactic acid)
5) analysis of oral flora
6) Physical activity

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who diagnosed as PAH or CTEPH in our institution.Inclusion criteia of patients were as follows.

1) adult patients (>20years old)
2) Mean pulmonary arterial pressure was above 25mmHg
3) Patients give written informed consents

Healthy control subjects are recruited from staffs of our institution. Inclusion criteria of healthy control subjects are as follows.

1) adult patients (>20years old)
2) Patients give written informed consents

Key exclusion criteria

Exclusion criteria of PH patients or healthycontrol subjects are as follows.

1) uncontrolled diabetes mellitus
2) history of myocardial infarction
3) history of unstable angina pectoris
4) subjects with severe liver dysfunction (AST or ALT >150)
5) subjects with severe renal dysfunction (BUN >30mg/dl or Creatinine >2.0mg/dl)
6) pregnant female subjects
7) breast feeding female subjects
8) Exclusion by Investigators in safety

Target sample size

40

Name of lead principal investigator

1st name	Takayuki
Middle name
Last name	Jujo

Organization

Graduated School of Medicine, Chiba University

Division name

Department of Advanced Medicine in Pulmonary Hypertension

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-Ku, Chiba City, 260-8670, Japan

TEL

043-222-7171

Email

naikamo_resp19184@yahoo.co.jp

Name of contact person

1st name	Takayuki
Middle name
Last name	Jujo

Organization

Graduated School of Medicine, Chiba University

Division name

Department of Advanced Medicine in Pulmonary Hypertension

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-Ku, Chiba City, 260-8670, Japan

TEL

043-222-7171

Homepage URL

Email

naikamo_resp19184@yahoo.co.jp

Institute

Graduated School of Medicine, Chiba University

Institute

Department

Personal name

Organization

Scientific Research (Japan Society for the Promotion of Science KAKENHI)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduated School of Medicine, Chiba University

Address

1-8-1 Inohana, Chuo-Ku, Chiba City, 260-8670, Japan

Tel

043-2222-7171

Email

igaku-rinri@office.chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

千葉大学医学部附属病院

Date of disclosure of the study information

2017

Year

01

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017

Year

01

Month

12

Day

Date of IRB

2018

Year

03

Month

01

Day

Anticipated trial start date

2018

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

None

Registered date

2017

Year

01

Month

12

Day

Last modified on

2019

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029510