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An Exploratory Study on the Relationship Between Right Ventricular Isovolumic Relaxation Time, Pulmonary Vascular Load, and Clinical Outcomes in Patients with COPD

An Exploratory Study on the Relationship Between Right Ventricular Isovolumic Relaxation Time, Pulmonary Vascular Load, and Clinical Outcomes in Patients with COPD - COPD-IRT Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059694
Enrollment
60
Registered
2025-11-12
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

None listed

Sponsors

Nippon Medical School Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactYosuke Tanaka

Nippon Medical School Hospital Department of Respiratory Medicine

yosuke-t@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026