HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disorder
• Interventions: Other: Sham Oxygen therapy; Other: Supplemental oxygen therapy

• Registration Number: NCT06084559
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2023-07-05
• Study First Submitted: 2023-08-10
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo (ambient hypoxic air at 2840m)	Sham Oxygen therapy	Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir
SOT (high flow supplemental oxygen therapy)	Supplemental oxygen therapy	SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary Artery Pressure with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask

Secondary Outcome Measures

Name	Time	Method
Change in ph by arterial blood gases with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in right atrial area with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in right heart strain with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in PaO2 by arterial blood gases with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in Cardiac Output with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in right to left heart diameter ratio with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask
Change in PaCO2 by arterial blood gases with SOT vs. placebo	at 15 min of breathing ambient air or supplemental oxygen	Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask

Trial Locations

Locations (1)

University Hospital Zürich; 🇨🇭 Zurich, Switzerland