Back to resultsHA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)
Primary Purpose
Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Supplemental oxygen therapy
Sham Oxygen therapy
Sponsored by
About this trial
This is an interventional other trial for Pulmonary Vascular Disorder focused on measuring pulmonary hypertension, hypoxia, supplemental oxygen, 6-minute walk distance
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)
Sites / Locations
- University Hospital Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Placebo (ambient hypoxic air at 2840m)
SOT (high flow supplemental oxygen therapy)
Arm Description
Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir
SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06084559
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Vascular Disorder, Pulmonary Artery Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Keywords
pulmonary hypertension, hypoxia, supplemental oxygen, 6-minute walk distance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant works as its own perfect control
Masking
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
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo (ambient hypoxic air at 2840m)
Arm Type
Sham Comparator
Arm Description
Ambient hypoxic air at 2840 m will be applied via a facial mask with reservoir
Arm Title
SOT (high flow supplemental oxygen therapy)
Arm Type
Experimental
Arm Description
SOT (supplemental oxygen therapy) at a flow of 10 l/min will be applied via a facial mask with reservoir
Intervention Type
Other
Intervention Name(s)
Supplemental oxygen therapy
Intervention Description
Mobile oxygen via pressurized bottle or mobile oxygen concentrator will be applied
Intervention Type
Other
Intervention Name(s)
Sham Oxygen therapy
Other Intervention Name(s)
Placebo
Intervention Description
Patients will reveice pressurized air via a nasal cannula
Primary Outcome Measure Information:
Title
Change in Pulmonary Artery Pressure with SOT vs. placebo
Description
Change in PAP in mmHg assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Secondary Outcome Measure Information:
Title
Change in Cardiac Output with SOT vs. placebo
Description
Change in cardiac output (l/min) assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in right to left heart diameter ratio with SOT vs. placebo
Description
Change in right to left heart diameter ratio assessed by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT vs. placebo
Description
Change in tricuspid annular plane systolic excursion (TAPSE) with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in right atrial area with SOT vs. placebo
Description
Change in right atrial area by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in right heart strain with SOT vs. placebo
Description
Change in in right heart strain by echocardiography with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in ph by arterial blood gases with SOT vs. placebo
Description
Changes in ph by arterial blood gases SaO2, PaO2, PaCO2 with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in PaO2 by arterial blood gases with SOT vs. placebo
Description
Changes in PaO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
Title
Change in PaCO2 by arterial blood gases with SOT vs. placebo
Description
Changes in PaCO2 by arterial blood gases with SOT compared to ambient air (placebo) 10l/min via facial mask
Time Frame
at 15 min of breathing ambient air or supplemental oxygen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof. Dr.
Organizational Affiliation
University Hospital Zurich, Departement of Pulmonology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo Hoyos, Dr.
Organizational Affiliation
Carlos Adrade Marin Hospital of Quito, Equador
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zürich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
HA Residents With PVD, Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) With and Without Supplemental Oxygen Therapy (SOT)
We'll reach out to this number within 24 hrs