UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025460 |
|---|---|
| Receipt number | 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 | 2024/03/01 21:24:39 |
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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
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
m-ishiyama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
LDH-PH study Project Office
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000028118&flwp_key=1010ovDlpHg
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000028118&flwp_key=1010ovDlpHg
Number of participants that the trial has enrolled
100
Results
Right heart catheterization revealed that 48 patients had non-PH, 30 had Ipc-PH, and 20 had Cpc-PH. PVR and SVR at 30 minutes after fasudil administration were 17% lower in the Ipc-PH group and 28% lower in the Cpc-PH group. Mean pulmonary artery wedge pressure was 19% lower in the Ipc-PH group and 12% lower in the Cpc-P group. Cardiac coefficient increased 9% in the Ipc-PH group and 11% in the Cpc-PH group.
Results date posted
| 2024 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
Mean age of patients were 71, 68, and 72 years in the Non-PH (n=48), Passive-PH (n=30), and Reactive-PH (n=20) groups, respectively.
Participant flow
To compare hemodynamic changes before and after 30 minutes of continuous administration of Fasudil, a Rho kinase inhibitor, in 100 patients admitted for heart failure who were catheterized and found to have pulmonary hypertension (PH).
Adverse events
No adverse events were observed.
Outcome measures
The primary endpoint will be the percent change in pulmonary vascular resistance with Fasudil (Reactive PH group), and the secondary endpoints will be the percent change in pulmonary vascular resistance with Fasudil (Passive PH group), percent change in cardiac coefficient, and mean pulmonary artery wedge pressure.
Plan to share IPD
We don't have plan to share IPD.
IPD sharing Plan description
We don't have plan to share IPD.
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
January 4, 2023, 100 cases enrolled.
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028118
