Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Artery Hypertension, Pulmonary Vascular Disease
Conditions
Keywords
Pulmonary Hypertension, Hypoxia, Supplemental Oxygen Therapy, Pulmonary arterial hypertension, Chronic Thromboembolic Pulmonary Hypertension, High altitude, Pulmonary vascular disease
Brief summary
The investigators aim to study the effect of SOT in participants with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on 6-minute walk distance (6MWD) assessed at 2840m.
Detailed description
Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.
Interventions
OTHER6-minute walk distance (6MWD) test
6-minute walk distance (6MWD) test will be performed according to clinical standards
OTHER6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal)
6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (3l/min, nasal)
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each participant works as its own perfect control
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
IInclusion Criteria: * Adult patients 18-80 years old of both genders, * Residence \> 2500m of altitude * diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines * Patients stable on therapy * New York Heart Association (NYHA) functional class I-III * Provided written informed consent to participate in the study.
Exclusion criteria
* Age \<18 years or \>80 years * unstable condition * Patients who cannot follow the study investigations, patient permanently living \< 2500m. * Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (\>20 cigarettes/day) * Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) \<80% on ambient air. * Patients with chronic mountain sickness (Hemoglobin \> 19 g/dl in women, \>21 g/dl in men) * Patient with a non-corrected ventricular septum defect * Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m | after 6 minute | Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m | 6 minutes | Change of the arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m |
| Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m | 6 minutes | Change of heart rate (bpm) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m |
| Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m | 6 minutes | Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m |
| Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m | 6 minutes | Change of Borg dyspnea scale at rest and at peak 6MWD with SOT 3l /min vs. ambient air at 2840 m |
Countries
Switzerland
Outcome results
None listed