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

Pulmonary Arterial Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384534
• Other study ID #: PVD_6MWD_SOT
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: University of Zurich
• Contact: Silvia Ulrich, Prof. Dr.
• Phone: +41442552220
• Email: silvia.ulrich[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum 18 years of age

• Written informed consent

• Patients with diagnosed pulmonary arterial hypertension (PAH), distal chronic thromboembolic pulmonary hypertension (CTEPH)

• Former desaturation under exercise defined as Spo2-decrease >3%

• Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria:

• Severe hypoxemia needing supplemental oxygen therapy defined as partial pressure of O2 (PaO2) < 6.9 Kilopascal (kPa)

• Pregnancy

• Unability or contraindications to undergo the investigated intervention

• Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc

Related Conditions & MeSH terms

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

Intervention

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
• 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)

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air	Change in 6MWD in meter between SOT via nasal cannula vs. ambient air	after 6 minutes
Secondary	SpO2 at rest and peak 6MWD with SOT vs. ambient air	Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air	after 6 minutes
Secondary	Heart rate at rest and peak 6MWD with SOT vs. ambient air	Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air	after 6 minutes
Secondary	Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air	Change of Borg dyspnea scale at rest and at peak 6MWD with SOT vs. ambient air	6 minutes
Secondary	Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air	Change of Borg leg fatigue scale at rest and at peak 6MWD with SOT vs. ambient air	6 minutes
Secondary	Blood pressure at rest and peak 6MWD with SOT vs. ambient air	Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air	after 6 minutes