Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Vascular Disorder
Conditions
Keywords
Pulmonary Hypertension, Supplemental Oxygen Therapy, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Vascular Disease, 6 Minute Walking Distance
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.
Interventions
6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
OTHER6-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)
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each participant is its own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air | after 6 minutes | Change in 6MWD in meter between SOT via nasal cannula vs. ambient air |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 at rest and peak 6MWD with SOT vs. ambient air | after 6 minutes | Change of the arterial oxygen saturation by pulse oximeter (SpO2) at rest and at peak 6MWD with SOT approximately 3l /min vs. ambient air |
| Heart rate at rest and peak 6MWD with SOT vs. ambient air | after 6 minutes | Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air |
| Borg dyspnea atrest and peak 6MWD with SOT vs. ambient air | 6 minutes | Change of Borg dyspnea scale (CR10, 0-10 where 10 is the worst dyspnea) at rest and at peak 6MWD with SOT vs. ambient air |
| Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air | 6 minutes | Change of Borg leg fatigue scale (CR10, 0-10 where 10 is the strongest led fatugue) at rest and at peak 6MWD with SOT vs. ambient air |
| Blood pressure at rest and peak 6MWD with SOT vs. ambient air | after 6 minutes | Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air |
Countries
Switzerland
Outcome results
None listed