Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-30 @ 2:13 PM
Study NCT ID:
NCT06384534
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2024-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: