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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Vascular Disorder
• Intervention / Treatment: Other: Sham Oxygen therapy; Other: Supplemental oxygen therapy

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Placebo (ambient hypoxic air at 2840m); Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir	Other: Sham Oxygen therapy; Patients will reveice pressurized air via a nasal cannula; Other Names: Placebo
Experimental: SOT (high flow supplemental oxygen therapy); SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir	Other: Supplemental oxygen therapy; Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Silvia Ulrich, Prof. Dr., University Hospital Zurich, Departement of Pulmonology; Principal Investigator: Rodrigo Hoyos, Dr., Carlos Adrade Marin Hospital of Quito, Equador

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary hypertension; hypoxia; supplemental oxygen; 6-minute walk distance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Vascular Diseases; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: PVD_HA_SOT_PAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Otherwise, we will share anonymized research data after publication on a open access repository according to FAIR principles.

Decision about the best suitable plattform is ongoing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No