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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026985
Receipt No. 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 2017/04/13

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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
Middle name
Last name Takahisa Kondo
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Medicine of Cardiopulmonary Disease
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2138
Email takahisa@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Kondo
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Medicine of Cardiopulmonary Disease
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL 052-744-2138
Homepage URL
Email takahisa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

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
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
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
Anticipated trial start date
2017 Year 04 Month 13 Day
Last follow-up date
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
2017 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030939

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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