UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059694 |
|---|---|
| Receipt number | R000068278 |
| Scientific Title | An Exploratory Study on the Relationship Between Right Ventricular Isovolumic Relaxation Time, Pulmonary Vascular Load, and Clinical Outcomes in Patients with COPD |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/28 08:33:38 |
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Basic information
Public title
An Exploratory Study on the Relationship Between Right Ventricular Isovolumic Relaxation Time, Pulmonary Vascular Load, and Clinical Outcomes in Patients with COPD
Acronym
COPD-IRT Study
Scientific Title
An Exploratory Study on the Relationship Between Right Ventricular Isovolumic Relaxation Time, Pulmonary Vascular Load, and Clinical Outcomes in Patients with COPD
Scientific Title:Acronym
COPD-IRT Study
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine whether right ventricular isovolumetric relaxation time (IRT) obtained by echocardiography can serve as a noninvasive indicator of pulmonary vascular resistance (PVR) measured by right heart catheterization in patients with Chronic Obstructive Pulmonary Disease (COPD)
Basic objectives2
Others
Basic objectives -Others
Observational validation of diagnostic/physiologic association. To assess the extent to which echocardiographic isovolumetric relaxation time (IRT) reflects invasively measured pulmonary vascular resistance (PVR), focusing on continuous associations.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between right ventricular isovolumetric relaxation time (IRT) measured by echocardiography and pulmonary vascular resistance index (PVRI) measured by right heart catheterization.
The strength of the association will be evaluated using correlation coefficients (Pearson or Spearman) and linear regression analysis.
Key secondary outcomes
Association between IRT and unindexed pulmonary vascular resistance (PVR).
Association between IRT and clinical parameters, including mMRC dyspnea score, 6-minute walk distance (6MWD), and treadmill exercise test (TMET) performance.
Correlation between PVRI and %FEV1, %DLCO, and mean pulmonary arterial pressure (mPAP).
Comparison of echocardiographic parameters (IRT, PAAcT, TEI index, etc) between COPD patients with and without pulmonary hypertension.
Correlation between IRT and pulmonary function parameters (%DLCO, %FEV1).
Association between IRT and hemodynamic variables obtained from right heart catheterization (mPAP, PAWP, CI, SvO2).
Comparison of IRT values between patients with and without pulmonary hypertension (PH).
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults aged between 20 and 80 years.
Patients diagnosed with chronic obstructive pulmonary disease (COPD) by respiratory specialists according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Clinically stable condition for at least 3 months, with no need for treatment modification.
Underwent both echocardiographic and right heart catheterization (RHC) examinations for the evaluation of exertional dyspnea.
Complete and analyzable clinical, echocardiographic, and hemodynamic data available.
Key exclusion criteria
Patients were excluded if they met any of the following criteria:
Pulmonary hypertension (PH) caused by etiologies other than COPD (e.g., interstitial lung disease, pulmonary embolism).
Left heart disease defined as left ventricular ejection fraction (LVEF) < 50% or moderate to severe valvular heart disease.
Systemic inflammatory diseases or collagen vascular disorders.
Pulmonary artery wedge pressure (PAWP) > 15 mmHg.
Treatment with systemic vasodilators or calcium channel blockers, or recent use of these agents.
Comorbid conditions unrelated to COPD that significantly limit physical activity (for example, neuromuscular or orthopedic disorders).
Incomplete hemodynamic or echocardiographic data or missing essential parameters.
Clinical features suggesting asthma or asthma COPD overlap (ACO), including:
Bronchodilator reversibility in FEV1 greater than or equal to 200 mL,
Blood eosinophil count greater than 150 cells per micro liter,
History of atopy, or
Serum IgE level greater than 170 IU per mL.
Atrial fibrillation or significant arrhythmias that make time interval measurement difficult.
Combined pulmonary fibrosis and emphysema (CPFE) defined as fibrotic changes occupying more than 10 percent of total lung field on high resolution computed tomography (HRCT).
Patients with minimal paraseptal fibrosis or traction bronchiectasis involving less than 10 percent of the lung field were included.
Target sample size
60
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 Hospital
Institute
Department
Personal name
Yosuke Tanaka
Funding Source
Organization
Nippon Medical School Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 12 | 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
58
Results
In 58 stable COPD patients evaluated by RHC and echocardiography during the same admission, the PH group showed higher mPAP/PVR and prolonged IRT. IRT correlated strongly with PVRI and was associated with dyspnea and 6MWD. Subgroup analysis confirmed stepwise increases in mPAP, PVR, and IRT, indicating that IRT may reflect early pulmonary vascular load.
Results date posted
| 2025 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 58 patients with stable chronic obstructive pulmonary disease (COPD) were enrolled. All participants had a history of smoking, and none were current smokers. The mean age was XX years, and the majority were male. All patients were hospitalized for evaluation of exertional dyspnea and underwent both right heart catheterization and comprehensive echocardiography during the same admission.
Based on hemodynamic data, 30 patients were classified into the pulmonary hypertension (PH) group and 28 into the non-PH group. The PH group showed lower DLCO and higher mMRC dyspnea scores, whereas FEV1 and NT-proBNP levels were similar between the two groups.
Participant flow
We consecutively identified 58 patients with stable chronic obstructive pulmonary disease (COPD) who were hospitalized for evaluation of exertional dyspnea and underwent both right heart catheterization and comprehensive echocardiography during the same admission. No patients were excluded based on eligibility criteria, and all 58 patients were included in the final analysis. According to the hemodynamic findings, 30 patients were classified into the pulmonary hypertension (PH) group and 28 into the non-PH group.
Adverse events
This study is a retrospective observational analysis, and no additional interventions, treatments, or procedures are performed for research purposes.
All examinations, including right heart catheterization and echocardiography, were conducted as part of routine clinical care.
Therefore, no adverse events attributable to the study itself are expected.
If any unforeseen ethical issues or unexpected findings arise in relation to the study, they will be promptly reported to the principal investigator and the institutional ethics committee.
Outcome measures
Primary Outcome
1. Correlation coefficient between isovolumetric relaxation time (IRT) and pulmonary vascular resistance index (PVRI), evaluating whether IRT can serve as a noninvasive indicator of pulmonary vascular load.
Secondary Outcomes
2. Association between IRT and exertional dyspnea (mMRC score).
3. Association between IRT and 6-minute walk distance (6MWD).
4. Associations between IRT and other echocardiographic parameters (PAAcT, Tei index, etc.).
5. Stepwise changes in mPAP, PVR, PAAcT, and IRT across subgroups (No-PH / Borderline-PH / Definite-PH).
6. Associations of DLCO and FEV1 with hemodynamic parameters (mPAP, PVR).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study is a single-center, retrospective observational study conducted at Nippon Medical School Hospital, including patients who underwent right heart catheterization and echocardiography between October 2021 and October 2025. No new interventions or patient recruitment were performed; anonymized existing clinical data were analyzed. The study was conducted under the comprehensive ethical approval of the Institutional Review Board of Nippon Medical School Hospital, with individual consent waived by the opt-out policy.
Although the study protocol was finalized in July 2025, the protocol fixation date was set to April 1, 2020, for consistency within the UMIN registration system, as this is a retrospective study.
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068278
