UMIN-CTR Clinical Trial

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)
Email	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
Email	yasuik@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033720