UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026985 |
|---|---|
| Receipt number | R000030939 |
| Scientific Title | Retrospective study of the prognosis of Japanese patients with pulmonary hypertension |
| Date of disclosure of the study information | 2017/04/15 |
| Last modified on | 2021/09/02 17:05:57 |
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Basic information
Public title
Retrospective study of the prognosis of Japanese patients with pulmonary hypertension
Acronym
Retrospective study of the prognosis of Japanese patients with pulmonary hypertension
Scientific Title
Retrospective study of the prognosis of Japanese patients with pulmonary hypertension
Scientific Title:Acronym
Retrospective study of the prognosis of Japanese patients with pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary hypertension such as pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) is a disease with poor prognosis, even though several specific drugs are available.
In this retrosepctive study, primary endpoint is a composite endpoint of death and worsening of pulmonary hypertension. In addition, we evaluate parameters such as hemodynamics, cardiac function, pulmonary function or exercise tolerance to assess the relationship between these parameters and known prognostic factors.
Basic objectives2
Others
Basic objectives -Others
In this retrosepctive study, we also evaluate parameters such as hemodynamics, cardiac function, pulmonary function or exercise tolerance to assess the relationship between these parameters and known prognostic factors.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In this study, primary end point is composite endpoint which meets the either criteria of the followings.
1) all cause death (cardiovascular death/ non-cardiovascular death)
2) worsening of pulmonary hypertension
worsening of pulmonary hypertension is defined as a condition which meets both of
the criteria as follows: a) worsening of
the symptom due to pulmonary hypertension, b) necessity of adding oral pulmonary vasodilators, intravenous inotropes or intravenous vasopressors.
worsening of the symptom due to pulmonary hypertension is defined as a condition which meets either criteria as follows: a) worsening of WHO functional class, b) worsening of the symptom due to rright heart failure and diuretics dose needs to be increased.
3) Necessity of any treatment as follows:
atrial septostomy, lung transplantation, initiation of treatment with IV or SC prostanoids.
Key secondary outcomes
1) death due to PH or hospitalization due to worsening of PH
2) worsening of the symptom due to pulmonary hypertension
3) change of hemodynamic parameters
4) change of the symptom using questionare. (PM-ADL8/SF-8/HADS)
5) change of laboratory examination
6) change of echocardiographic parameters
7) change of pulmonary function test
8) tapering or withdrawal of home oxygen therapy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pulmonary hypertension who have or had been treated in our hospital and satisfy the following criteria.
1) pulmonary hypertension
Group 1, pulmonary arterial hypertension (PAH)
Group 4, chronic thromboembolic pulmonary hypertension (CTEPH)
2) ages 16 and above
3) WHO functional class 1 and above
Key exclusion criteria
Since this study is a retrospective study, we investigate all the cases which satisfy the inclusion criteria.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Adachi |
Organization
Nagoya University Hospital
Division name
Department of Cardiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2138
sadachi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Nakano |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2138
Homepage URL
middlefield0608@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
Tel
052-744-2479
ethics@med.nagoya-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
| 2017 | Year | 04 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study. We enrolled patients with pulmonary hypertension who were admitted to our institution since 2005 and satisfy the inclusion criteria.
Management information
Registered date
| 2017 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030939
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
