UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025652 |
|---|---|
| Receipt number | R000029510 |
| Scientific Title | Investigation of relationship between the pathogenesis of pulmonary hypertension and dysbiosis |
| Date of disclosure of the study information | 2017/01/12 |
| Last modified on | 2019/12/13 18:50:46 |
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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
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
naikamo_resp19184@yahoo.co.jp
Sponsor or person
Institute
Graduated School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029510
