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

UMIN ID: UMIN000055468

Registered date:10/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Idiopathic Pulmonary Fibrosis
• Date of first enrollment: 2020/10/11
• Target sample size: 50
• 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 idiopathic pulmonary fibrosis (IPF).
• 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 idiopathic pulmonary fibrosis (IPF).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who had received bosentan or any other drug specific for PAH (e.g., phosphodiestetrase type 5 [PDE-5] inhibitors, endothelin receptor antagonists, or prostaglandin analogs) prior to their enrollment 2) Patients with any disease that could cause right heart overload 3) Patients with hypoxia during 6MWT (PaO2 < 60 mmHg)*. * Excluded were those whose hypoxia (PaO2 < 60 mmHg) had been corrected with LTOT (i.e., those in whom LTOT is in place to ensure PaO2 > 60 mmHg both at rest and during 6MWT, who were deemed equivalent to IPF patients receiving routine therapy in clinical practice to allow them to be monitored for changes in their condition, prognosis and functional capacity for ADL). 4) Women who were pregnant or might have been pregnant, and who were lactating 5) Other patients judged by the investigator to be ineligible for this study (e.g., those with any disease or condition other than IPF that might affect their ADL, such as arrhythmia, LV failure, pulmonary thromboembolism, connective tissue diseases, intervertebral disc herniation, as they were confirmed by history taking, physical examination, chest x-ray, echocardiography [ECG], lung perfusion scintigraphy, and measurements of various parameters conducted during the run-in period).

Related Information

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