UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059984 |
|---|---|
| Receipt number | R000068591 |
| Scientific Title | Retrospective Observational Study on the Association Between Right-Ventricular Isovolumetric Relaxation Time and Pulmonary Vascular Resistance in Idiopathic Pulmonary Fibrosis |
| Date of disclosure of the study information | 2026/01/10 |
| Last modified on | 2026/01/10 19:44:16 |
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Basic information
Public title
Noninvasive Assessment of Pulmonary Vascular Resistance Using Right-Ventricular IRT in Idiopathic Pulmonary Fibrosis
Acronym
IPF-IRT Study
Scientific Title
Retrospective Observational Study on the Association Between Right-Ventricular Isovolumetric Relaxation Time and Pulmonary Vascular Resistance in Idiopathic Pulmonary Fibrosis
Scientific Title:Acronym
IPF-IRT Study
Region
| Japan |
Condition
Condition
Idiopathic Pulmonary Fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether right ventricular isovolumetric relaxation time (IRT) serves as a useful noninvasive marker of pulmonary vascular resistance (PVR) and pulmonary vascular resistance index (PVRI) in patients with idiopathic pulmonary fibrosis (IPF).
Basic objectives2
Others
Basic objectives -Others
This study is an exploratory observational investigation designed to evaluate the association between right ventricular isovolumetric relaxation time (IRT) and the pulmonary vascular resistance index (PVRI) in patients with idiopathic pulmonary fibrosis (IPF).
The objective is to determine whether IRT can serve as a feasible noninvasive marker of pulmonary vascular resistance in clinical practice.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation coefficient between isovolumetric relaxation time (IRT) and pulmonary vascular resistance index (PVRI) obtained from transthoracic echocardiography and right heart catheterization performed during the same hospitalization period.
Key secondary outcomes
Correlation between IRT and pulmonary vascular resistance (PVR).
Correlation between IRT and mean pulmonary arterial pressure (mPAP).
Association between IRT and right ventricular-pulmonary arterial coupling indices (e.g., TAPSE/sPAP).
Comparison of IRT between patients with pulmonary hypertension (PH) and those without PH.
Correlation between pulmonary artery acceleration time (PAAcT) and PVRI.
Correlation of pulmonary function parameters (FVC, DLCO) with PVR and PVRI.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age >= 20 years
Diagnosis of idiopathic pulmonary fibrosis (IPF) based on ATS/ERS/JRS/ALAT guidelines
Transthoracic echocardiography and right heart catheterization performed during the same hospitalization under stable conditions
No acute exacerbation, infection, hospitalization, or corticosteroid escalation within the previous 4 to 8 weeks
Antifibrotic therapy, if used, must be stable for at least 4 weeks before evaluation
Complete hemodynamic data including mPAP, PAWP, and cardiac output
Doppler waveforms for IRT and PAAT that are suitable for analysis
CPFE cases are excluded (mild emphysema <10 percent is allowed)
In addition,
Patients receiving guideline-based long-term oxygen therapy (LTOT) at the minimum required flow for IPF-related hypoxemia and/or low-dose diuretics for congestion related to IPF-associated pulmonary hypertension were eligible, provided that these treatments had been stable for at least 4 weeks before the index hospitalization.
Key exclusion criteria
Left heart disease (LVEF < 50 percent, moderate or greater valvular disease, hypertrophic or restrictive cardiomyopathy)
PAWP > 15 mmHg
Interstitial lung diseases other than IPF
Chronic thromboembolic disease confirmed by CT pulmonary angiography or ventilation perfusion scanning
Atrial fibrillation or significant arrhythmias
Acoustic windows inadequate for Doppler evaluation
Use of pulmonary hypertension targeted therapy before echocardiography or right heart catheterization
Missing essential echocardiographic or hemodynamic data
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
yosuke-t@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
Homepage URL
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Yosuke Tanaka
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba Hokusoh Hospital, Nippon Medical School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
Tel
03-3822-2131
nms_fuzokurinri@nms.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
日本医科大学付属病院（東京都）、
日本医科大学千葉北総病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 10 | 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
180
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 31 | Day |
Other
Other related information
This study is a two-center, retrospective observational analysis conducted at Nippon Medical School Hospital and Nippon Medical School Chiba Hokusou Hospital. Clinical data from right heart catheterization and transthoracic echocardiography performed between April 2015 and November 2025 will be analyzed. No new interventions or prospective patient recruitment will be performed; instead, anonymized existing clinical data will be used.
The study is conducted under the comprehensive ethical approval issued by the Institutional Review Board of Nippon Medical School Hospital (Approval No. B-2020-175), which applies uniformly across affiliated institutions including Chiba Hokusou Hospital, Musashi Kosugi Hospital, and Tama Nagayama Hospital. Therefore, no additional IRB approval is required at the secondary site. Informed consent is waived via an opt-out process.
This study integrates datasets from both centers to enable validation analyses and evaluate the reproducibility of associations between isovolumetric relaxation time (IRT) and pulmonary vascular resistance metrics. The results are intended for submission to an international peer-reviewed journal.
Although the study protocol was finalized in 2025, for consistency with UMIN system requirements in retrospective studies, the protocol fixation date is recorded as March 1, 2015, and data collection is considered complete as of November 30, 2025.
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068591
