UMIN-CTR Clinical Trial

Basic information
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
Condition	Pulmonary arterial hypertension Chronic thromboembolic pulmonary hyperetension
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

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	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

Research contact person
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

Public contact
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

Sponsor
Institute	Graduated School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Scientific Research (Japan Society for the Promotion of Science KAKENHI)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 12 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 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
Other related information	None

Management information
Registered date	2017 Year 01 Month 12 Day
Last modified on	2019 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029510