Clinical trial NCT06384534: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Vascular Disorder
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Arterial Hypertension
Keywords: Pulmonary Hypertension
Supplemental Oxygen Therapy
Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Vascular Disease
6 Minute Walking Distance
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant is its own control
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air
timeFrame: after 6 minutes
Secondary outcomes:
measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
measure: Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air
timeFrame: 6 minutes
measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air
timeFrame: 6 minutes
measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air
timeFrame: after 6 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University Hospital Zurich, Department of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: