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

Sponsor

University of Zurich (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06084559

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Vascular Disorder Pulmonary Artery Hypertension Chronic Thromboembolic Pulmonary Hypertension	Other: Supplemental oxygen therapy Other: Sham Oxygen therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each participant works as its own perfect controlEach participant works as its own perfect control

Masking:

Single (Participant)

Masking Description:

Sham SOT (placebo, ambient hypoxic air at 2840m) versus high-flow oxygen 10l/min both via a facial mask with reservoir will be applied

Primary Purpose:

Other

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

Actual Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zürich	Zurich		Switzerland	8091

Sponsors and Collaborators

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