Effect of Supplemental Oxygen Therapy (SOT) in Patients 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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Zurich
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Ambient air
Patient will perform tests on ambient air at 2840 m
Intervention: 6-minute walk distance (6MWD) test (Other)
SOT via nasal canula
Supplemental oxygen therapy (SOT) at 3l/min will be provided via a nasal cannula from a small oxygen bottle carried on the back according to standard care
Intervention: 6-minute walk distance (6MWD) test with supplemental oxygen (3 l/min, nasal) (Other)
Outcomes
Primary Outcomes
6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
Time Frame: after 6 minute
Change in 6MWD in meter between SOT 3l/min via nasal cannula vs. ambient air at 2840m
Secondary Outcomes
- SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)
- Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)
- Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)
- Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m(6 minutes)