UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009458
Receipt No. R000011111
Scientific Title Metabolism and inflammation researches in patients with pulmonary arterial hypertension
Date of disclosure of the study information 2012/12/02
Last modified on 2012/12/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Metabolism and inflammation researches in patients with pulmonary arterial hypertension
Acronym Metabolism and inflammation researches in patients with PAH
Scientific Title Metabolism and inflammation researches in patients with pulmonary arterial hypertension
Scientific Title:Acronym Metabolism and inflammation researches in patients with PAH
Region
Japan

Condition
Condition pulmonary arterial hypertension
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the possibilities of plasma amino acid concentration, insulin resistance, and dyslipidemia as a biomarker in patients with pulmonary arterial hypertension
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence of clinical events such as the hospitalization for right-sided heart failure and survival.
Hemodynamic parameters obtained by right-sided heart catheterization, six minutes walk distance, serum BNP level.
Key secondary outcomes

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria pulmonary arterial hypertension
Key exclusion criteria patients who does not sign informed consent forms are excluded
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Satoh
Organization Kyorin University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 6-20-2, Shinkawa, Mitaka, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyorin University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email ryoji@ks.kyorin-u.ac.jp

Sponsor
Institute Second Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 12 Month 02 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 Open public recruiting
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information By elucidating the metabolic system, this study may demonstrate the possibilities of plasma amino acid concentration, insulin resistance, and dyslipidemia as a biomarker in patients with pulmonary arterial hypertension. This study may lead to the discovery of new biomarkers and new therapeutic agents.

Management information
Registered date
2012 Year 12 Month 02 Day
Last modified on
2012 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011111

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.