NCT06384534

Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)

Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-inferiority Trial in Patients With Exercise Induced Desaturation Due to Pulmonary Vascular Disease (PVD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).

Detailed description

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT approximately 3l/min via nasal cannula according to a randomized cross-over design. The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air. The effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Conditions

• Pulmonary Vascular Disorder
• Chronic Thromboembolic Pulmonary Hypertension
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
OTHER	6-minute walk distance (6MWD) test on ambient air	6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
OTHER	6-minute walk distance test with supplemental oxygen	6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-04-25
• Last updated: 2025-12-10

Locations

1 site across 1 country: Switzerland