An Exploratory Clinical Study on the Impact of Pulmonary Circulation on Patients with COPD

UMIN ID: UMIN000055594

Registered date:23/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrollment: 2020/09/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Right Heart Catheter

Outcome(s)

• Primary Outcome: To examine the relationship between pulmonary circulation parameters, including pulmonary vascular resistance (PVR) and the prognosis in patients with Chronic Obstructive Pulmonary Disease (COPD).
• Secondary Outcome: To examine the relationship between pulmonary circulation parameters, including pulmonary vascular resistance (PVR), and the activities of daily living (ADL) and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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).

Related Information

• Primary Sponsor: Nippon Medical School
• Source(s) of Monetary Support: Nippon Medical School