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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024463
Receipt No. R000028152
Scientific Title A study of myocardial cell dysfunction in right ventricle in patients with chronic thromboembolic pulmonary hypertension
Date of disclosure of the study information 2016/11/02
Last modified on 2016/11/02

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Basic information
Public title A study of myocardial cell dysfunction in right ventricle in patients with chronic thromboembolic pulmonary hypertension
Acronym A study of RV myocardial cell dysfunction in CTEPH
Scientific Title A study of myocardial cell dysfunction in right ventricle in patients with chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym A study of RV myocardial cell dysfunction in CTEPH
Region
Japan

Condition
Condition Chronic thromboembolic pulmonary hypertension: CTEPH
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To reveal metabolic alterations of right ventricle myocardial cells in CTEPH patients, right ventricle biopsy samples were evaluated in any of a variety of molecular biology procedures.
Basic objectives2 Others
Basic objectives -Others To reveal metabolic alterations of right ventricle myocardial cells in CTEPH patients, right ventricle were examined with FDG-PET and BMIPP scintigraphy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of mitochondrial dysfunction in right ventricle myocardial cells by using biopsy samples extracted during pulmonary endarterectomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Right ventricle biopsy performed during pulmonary endarterectomy
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
80 years-old >
Gender Male and Female
Key inclusion criteria Inclusion Criteria:
1. Males or females 20 years old or more and less than 80 years of age
2. Willing and able to complete informed consent form.
3. Documented diagnosis of CTEPH:
o Mean pulmonary arterial pressure >25 mm Hg, pulmonary capillary wedge pressure =/< 15 mm Hg and pulmonary vascular resistance >240 dynes/sec/cm5 (measured by catheter).
o Segmental perfusion defects with normal ventilation (measured by ventilation/perfusion scan); stable for at least 6 months after receiving stable doses of anticoagulants.
o Pulmonary arterial stenosis and/or obstruction (measured by pulmonary angiography and CT angiography).
4. CTEPH patients who are scheduled to undergo pulmonary endarterectomy.
Key exclusion criteria Exclusion Criteria:
1. Clinically significant biochemical abnormality.
2. Clinical evidence of pre-existing neuropathy.
3. Use of investigational product or device within 30 days prior to dosing, or known requirement for any investigational agent prior to completion of all scheduled study assessments.
4. Known to be positive for human immunodeficiency virus (HIV).
5. Additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities, including past history of myocardial infarction, unstable angina, and poorly controlled diabetes mellitus.
6. Blood results (performed within 14 days from study registration) as outlined below:
o Creatinine > 2.0 mg/dl
o BUN > 30 mg/dl
o ALT >150 U
o AST >150 U
7. Pregnant or lactating at screening, or planning to become pregnant (self or partner) at any time during study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichiro Sakao
Organization Graduate School of Medicine, Chiba University
Division name Department of Respirology (B2)
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670
TEL 043-222-7171
Email sakaos@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichiro Sakao
Organization Graduate School of Medicine, Chiba University
Division name Department of Respirology (B2)
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670
TEL 043-222-7171
Homepage URL
Email sakaos@faculty.chiba-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
2016 Year 11 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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