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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055468
Enrollment
50
Registered
2024-09-10
Start date
2020-10-11
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Sponsors

Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion 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).

Design outcomes

Primary

MeasureTime frame
To examine the relationship between pulmonary circulation parameters, including pulmonary vascular resistance (PVR) and the prognosis in patients with idiopathic pulmonary fibrosis (IPF).

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactYosuke Tanaka

Nippon Medical School Department of Respiratory Medicine

yosuke-t@nms.ac.jp0338222131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026