Back to resultsEffect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m
Primary Purpose
High Altitude Pulmonary Hypertension, Oxygen Therapy
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for High Altitude Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
- Informed consent as documented by signature
- PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion Criteria:
- resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
- exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- inability to follow the procedures of the study
- other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Sites / Locations
- Respiratory Clinic, University Hospital of Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxygen Therapy
Arm Description
Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
Outcomes
Primary Outcome Measures
Recovery from ARAHE
Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.
Secondary Outcome Measures
Constant work-rate exercise time
Difference with oxygen therapy at high altitude vs. low altitude in constant work-rate exercise time cycle exercise test at 75% Wmax at low altitude
Maximum work-rate in incremental ramp cycle exercise tests
Difference with oxygen therapy at high altitude vs. low altitude in maximal exercise capacity during a incremental ramp cycle exercise test
Hemodynamics
Difference with oxygen therapy at high altitude vs. low altitude in hemodynamics assessed by echocardiography at rest including pulmonary artery pressure, cardiac output, pulmonary vascular resistance and right heart function assessed as tricuspid plane systolic excursion and fractional area change.
Borg dyspnoea scale
Difference with oxygen therapy at high altitude vs. low altitude baseline in post-exercise Borg dyspnoea scale going from 1-10 scores with higher values meaning worse dyspnea
Visual Analogue Scale
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Visual Analogue Scale for dyspnoea, a 10cm line from left to right where patients have to add a cross-line with higher values meaning better feeling.
Cognitive testing
Difference with oxygen therapy at high altitude vs. low altitude baseline in cognitive function tests
sit-to-stand test
Difference with oxygen therapy at high altitude vs. low altitude baseline in sit-to-stand test
Sleep disordered breathing
Difference with oxygen therapy at high altitude vs. low altitude in sleep disordered breathing
6 minute walk test
Difference with oxygen therapy at high altitude vs. low altitude in 6 minute walk test
Acute Mountain Sickness Score
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Lake Louise acute mountain sickness score going from 0-12 points with mild AMS as 3-5 points, moderate AMS as 6-9 points, and severe AMS as 10-12 points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05112172
Brief Title
Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m
Official Title
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)
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
5. Study Description
Brief Summary
To study whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.
Detailed Description
Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Pulmonary Hypertension, Oxygen Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Therapy
Arm Type
Experimental
Arm Description
Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
Intervention Type
Other
Intervention Name(s)
Oxygen Therapy
Intervention Description
Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
Primary Outcome Measure Information:
Title
Recovery from ARAHE
Description
Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.
Time Frame
30 hours
Secondary Outcome Measure Information:
Title
Constant work-rate exercise time
Description
Difference with oxygen therapy at high altitude vs. low altitude in constant work-rate exercise time cycle exercise test at 75% Wmax at low altitude
Time Frame
30 hours
Title
Maximum work-rate in incremental ramp cycle exercise tests
Description
Difference with oxygen therapy at high altitude vs. low altitude in maximal exercise capacity during a incremental ramp cycle exercise test
Time Frame
30 hours
Title
Hemodynamics
Description
Difference with oxygen therapy at high altitude vs. low altitude in hemodynamics assessed by echocardiography at rest including pulmonary artery pressure, cardiac output, pulmonary vascular resistance and right heart function assessed as tricuspid plane systolic excursion and fractional area change.
Time Frame
30 hours
Title
Borg dyspnoea scale
Description
Difference with oxygen therapy at high altitude vs. low altitude baseline in post-exercise Borg dyspnoea scale going from 1-10 scores with higher values meaning worse dyspnea
Time Frame
30 hours
Title
Visual Analogue Scale
Description
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Visual Analogue Scale for dyspnoea, a 10cm line from left to right where patients have to add a cross-line with higher values meaning better feeling.
Time Frame
30 hours
Title
Cognitive testing
Description
Difference with oxygen therapy at high altitude vs. low altitude baseline in cognitive function tests
Time Frame
30 hours
Title
sit-to-stand test
Description
Difference with oxygen therapy at high altitude vs. low altitude baseline in sit-to-stand test
Time Frame
30 hours
Title
Sleep disordered breathing
Description
Difference with oxygen therapy at high altitude vs. low altitude in sleep disordered breathing
Time Frame
30 hours
Title
6 minute walk test
Description
Difference with oxygen therapy at high altitude vs. low altitude in 6 minute walk test
Time Frame
30 hours
Title
Acute Mountain Sickness Score
Description
Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Lake Louise acute mountain sickness score going from 0-12 points with mild AMS as 3-5 points, moderate AMS as 6-9 points, and severe AMS as 10-12 points.
Time Frame
30 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent as documented by signature
PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion Criteria:
resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
inability to follow the procedures of the study
other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m
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