UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029510 |
|---|---|
| Receipt number | R000033720 |
| Scientific Title | Evaluating Cardiac Function by 6MW Stress Echocardiography in Patients with Interstitial Lung Disease. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2022/04/17 21:12:45 |
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Basic information
Public title
Evaluating Cardiac Function by 6MW Stress Echocardiography in Patients with Interstitial Lung Disease.
Acronym
Evaluating Cardiac Function by 6MW Stress Echocardiography in Patients with Interstitial Lung Disease.
Scientific Title
Evaluating Cardiac Function by 6MW Stress Echocardiography in Patients with Interstitial Lung Disease.
Scientific Title:Acronym
Evaluating Cardiac Function by 6MW Stress Echocardiography in Patients with Interstitial Lung Disease.
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Interstitial lung disease (ILD) is a heterogeneous type of disorders that are characterized by inflammation and fibrosis in the alveolar structures, the pulmonary interstitium, and the small airways. Pulmonary hypertension (PH) is a strong predictor of mortality in patients with ILD. However, patients with ILD often have poor outcome even in the absence of PH. Early detection of PH is crucial to ensure that the patients appropriately receive timely treatment for the progressive clinical course.
Previously, it was reported that 6-min walk (6MW) stress echocardiography provided an incremental prognostic value of PH in patient with connective tissue disease. We hypothesized that 6MW stress echocardiography could be useful for early detection of PH in patients with ILD.
This study is aimed at evaluating the role of 6MW stress echocardiography in patients with ILD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Echocardiographic parameters (pre and post 6MW exercise)
Tricuspid regurgitation pressure gradient. (TRPG)
Time velocity integral of right ventricular outflow (RVOT VTI)
Tricuspid annular plane systolic excursion (TAPSE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
From August 2016 through December 2019, we will perform the 6MW stress echocardiography on patients who are hospitalized for ILD treatment at Department of Respiratory Medicine and Allergology, Sappro Medical University Hospital.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who were hospitalized for ILD treatment within the research period.
2.Patients who agreed to participate in the study.
Key exclusion criteria
Patients with post operation (chest/abdomen/head), pneumothorax, ischemic heart disease, aortic aneurysm, hemoptysis, pulmonary embolism, acute abdomen, poor control of hypertension, dementia, infectious disease, percent forced vital capacity <50 %, poor control of arrhythmia, moderate or severe valvular disease and severe heart failure were excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | kenji |
| Middle name | |
| Last name | Yasui |
Organization
Sapporo Medical University Hospital, Sapporo, Japan.
Division name
Division of laboratory medicine.
Zip code
060-8556
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan.
TEL
011-611-2111(36570)
yasuik@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yasui |
Organization
Sapporo Medical University Hospital, Sapporo, Japan.
Division name
Division of laboratory medicine.
Zip code
060-8556
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan.
TEL
011-611-2111(36570)
Homepage URL
yasuik@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University.
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University.
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
Sapporo Medical University.
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan.
Tel
011-611-2111
rskk@sapmed.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 | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033720
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