Clinical trial NCT06084559: HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) 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 Pulmonary Artery Pressure (PAP) and Other Hemodynamics by Echocardiography
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Vascular Disorder
Pulmonary Artery Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Keywords: pulmonary hypertension
hypoxia
supplemental oxygen
6-minute walk distance
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-10-16
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: To study the effect of SOT in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on pulmonary artery pressure (PAP) and other hemodynamics by echocardiography and in relation to blood gases at 2840m with and without SOT.

Detailed description: Patients 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 echocardiografy to assess PAP, cardiac output and other hemodynamics and arterial blood gas to assess SaO2, PaO2 and PaCO2 near their living altitude in Quito at 2840m whilst breathing ambient air or SOT at 10l/min flow via a face mask with reservoir.

Eligibility criteria: Inclusion 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: Change in Pulmonary Artery Pressure with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
Secondary outcomes:
measure: Change in Cardiac Output with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in right to left heart diameter ratio with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in right atrial area with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in right heart strain with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in ph by arterial blood gases with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in PaO2 by arterial blood gases with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
measure: Change in PaCO2 by arterial blood gases with SOT vs. placebo
timeFrame: at 15 min of breathing ambient air or supplemental oxygen
Other outcomes:
Locations:
city: Zurich
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: