Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with COPD who were enrolled under UMIN ID: UMIN000042159 and completed a two-year observation period. Patients aged 20 years or older, of either sex. Patients diagnosed with COPD at this hospital (WHO functional class II, III, or IV) who do not exhibit hypoxemia at rest or during the 6-minute walk test (6MWT). Patients with decreased activities of daily living (ADL) or dyspnea related to hypoxemia are excluded in order to minimize the influence of hypoxic pulmonary vasoconstriction (HPV) as a potential cause of pulmonary hypertension (PH) associated with reduced arterial oxygen pressure (PaO2 < 60 mmHg). Patients with hypoxemia (PaO2 < 60 mmHg) who are receiving long-term oxygen therapy (LTOT) and whose hypoxemia is adequately corrected are included. Patients with respiratory symptoms that remained stable for at least three months prior to enrollment, requiring no change in treatment, yet persistent and gradually progressive despite COPD therapy, who underwent right heart catheterization. Patients with exercise-induced elevated pulmonary artery pressure (eePAP) or mild PH requiring therapeutic intervention, characterized by pulmonary artery wedge pressure (PAWP) <= 15 mmHg and mean pulmonary artery pressure (mPAP) < 25 mmHg at rest, with exercise mPAP (mPAPOE) >= 30 mmHg or resting mPAP >= 25 mmHg but < 35 mmHg. Both inpatients and outpatients were eligible. All patients provided written informed consent before participation in the study.
Exclusion criteria
Exclusion criteria: Patients who have received or will receive bosentan or other PAH-specific medications (e.g., phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonists, or prostaglandin analogs) Patients with diseases that may cause right heart overload (During the registration process for this study, patients identified through echocardiography, electrocardiogram, oxygen saturation monitoring, imaging studies, etc., with diseases that may cause right heart overload, such as obstructive sleep apnea and cardiovascular comorbidities like HFpEF, were excluded.) Patients with PAWP exceeding 15 mmHg Patients with hypoxia (PaO2 < 60 mmHg) during the 6MWT [Patients in whom hypoxia (PaO2 < 60 mmHg) was corrected with long-term oxygen therapy (LTOT) (i.e., patients who received LTOT to ensure PaO2 > 60 mmHg at rest and during the 6MWT and were deemed equivalent to COPD patients receiving routine therapy in clinical practice, allowing monitoring of changes in their condition, prognosis, and ADL functional capacity) were excluded.] Patients with a history of asthma, a bronchodilator response (BDR) to 400 mcg of salbutamol with an FEV1 change of and or more than 200 mL, peripheral eosinophilia (>150 cells/mcL), typical asthma symptoms of atopy, or a history of IgE > 170 IU/ml Women who are pregnant, may be pregnant, or are lactating Other patients deemed ineligible for this study by the principal investigator (e.g., those with diseases or conditions other than COPD that might affect ADL, such as arrhythmias, left ventricular failure, pulmonary thromboembolism, connective tissue diseases, intervertebral disc herniation, as confirmed through history-taking, physical examination, chest X-ray, echocardiography, lung perfusion scintigraphy, and various parameter measurements conducted during the run-in period).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the relationship between pulmonary circulation parameters, including pulmonary vascular resistance (PVR) and the prognosis in patients with COPD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Associations between pulmonary circulatory parameters (PVR, IRT, TAPSE/PASP, %CSA, etc.) and pulmonary function indices (FEV1% predicted, DLCO% predicted, VC% predicted). Associations between pulmonary circulatory parameters and exercise capacity (6-minute walk distance [6MWD], treadmill exercise test metrics) and daily physical activity. Associations between pulmonary circulatory parameters and circulating biomarkers such as NT-proBNP. Prognostic value of pulmonary circulatory parameters for acute exacerbations, respiratory-related hospitalization, all-cause hospitalization, home-stay survival, and overall survival. Improvement in risk stratification when adding IRT to existing clinical prediction models (e.g., age, sex, FEV1%, DLCO%, TRV). | — |
Countries
Japan
Contacts
Public ContactYosuke Tanaka
Nippon Medical School Department of Respiratory Medicine
Outcome results
None listed