Clinical trial NCT06003244: High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Vascular Disease
Pulmonary Artery Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Hypoxia
Supplemental Oxygen Therapy
Pulmonary arterial hypertension
Chronic Thromboembolic Pulmonary Hypertension
High altitude
Pulmonary vascular disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant works as its own perfect control
Primary purpose: OTHER

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.

Eligibility 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)

Primary outcomes:
measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air at 2840m
timeFrame: after 6 minute
Secondary outcomes:
measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air at 2840m
timeFrame: 6 minutes
measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air at 2840m
timeFrame: 6 minutes
measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air at 2840m
timeFrame: 6 minutes
measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air at 2840m
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: University Hospital Zurich, Departement of Pulmonology
name: Silvia Ulrich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carlos Adrade Marin Hospital of Quito, Equador
name: Rodrigo Hoyos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: