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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025460
Receipt No. R000028118
Scientific Title Investigation of mechanisms of pulmonary hypertension due to left heart disease
Date of disclosure of the study information 2016/12/29
Last modified on 2019/07/01

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Basic information
Public title Investigation of mechanisms of pulmonary hypertension due to left heart disease
Acronym LHD-PH study
Scientific Title Investigation of mechanisms of pulmonary hypertension due to left heart disease
Scientific Title:Acronym LHD-PH study
Region
Japan

Condition
Condition pulmonary hypertension due to left heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the role of Rho/Rho-kinase signaling pathway in the in the pathogenesis of pulmonary hypertension due to left heart disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in pulmonary vascular resistance after 30 minutes infusion of Rho-kinase inhibitor
Key secondary outcomes Change of cardiac index, mean pulmonary wedge pressure and cGMP after 30 minutes infusion of Rho-kinase inhibitor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 a Rho-kinase inhibitor is administered over a period of 30
minutes during cardiac catheterization
Interventions/Control_2 no administration of Rho-kinase inhibitor
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 pulmonary hypertension due to left heart disease with NYHA classification 2-4
Key exclusion criteria 1) patients with severe primary valvular heart disease
2) patients with acute coronary syndrome
3) patients with carcinogenic shock
4) patients receiving mechanical ventilation
5) patients with pulmonary arterial hypertension and pulmonary hypertension due to lung disease and hypoxemia
6) patients with connective tissue disease
7) patients with chronic kidney disease stage 5
8) patients with pneumonia
9) patients of life expectancy is less than one year for the malignant tumor, etc
10) patients that might be pregnant or pregnant
11) patients research investigator or research sharing physician has determined to be inappropriate as a research subject
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kaoru
Middle name
Last name Dohi
Organization Mie University Hospital
Division name Department of Cardiology and Nephrology
Zip code 514-8507
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 059-231-5015
Email dohik@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Ishiyama
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrologyand Nephrology
Zip code 514-8507
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 059-231-5015
Homepage URL
Email m-ishiyama@clin.medic.mie-u.ac.jp

Sponsor
Institute LDH-PH study Project Office
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Mie University Graduate School of Medicine Ethics comittee
Address 2-174 Edobashi, Tsu 514-8507, Japan
Tel 059-232-1111
Email s-kenkyu3@mo.medic.mie-u.ac.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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 29 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
2016 Year 04 Month 20 Day
Date of IRB
2016 Year 04 Month 20 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028118

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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