UMIN-CTR Clinical Trial

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

Chronic thromboembolic pulmonary hypertension: CTEPH

Classification by specialty

Cardiology

Pneumology

Classification by malignancy

Others

Genomic information

YES

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

Primary outcomes

Evaluation of mitochondrial dysfunction in right ventricle myocardial cells by using biopsy samples extracted during pulmonary endarterectomy

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Seiichiro
Middle name
Last name	Sakao

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Respirology (B2)

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670

TEL

043-222-7171

Email

sakaos@faculty.chiba-u.jp

Name of contact person

1st name	Seiichiro
Middle name
Last name	Sakao

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Respirology (B2)

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670

TEL

043-222-7171

Homepage URL

Email

sakaos@faculty.chiba-u.jp

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical research center

Address

1-8-1 Ibnohana Cuoku Chiba

Tel

043-222-7171

Email

sakaos@faculty.chiba-u.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

5

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

Completed

Date of protocol fixation

2016

Year

09

Month

21

Day

Date of IRB

2016

Year

09

Month

21

Day

Anticipated trial start date

2016

Year

11

Month

15

Day

Last follow-up date

2020

Year

01

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

18

Day

Last modified on

2020

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028152