Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2021
CompletedStudy Start
First participant enrolled
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedMay 11, 2022
May 1, 2022
6 months
October 14, 2021
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 hours
Secondary Outcomes (10)
Constant work-rate exercise time
30 hours
Maximum work-rate in incremental ramp cycle exercise tests
30 hours
Hemodynamics
30 hours
Borg dyspnoea scale
30 hours
Visual Analogue Scale
30 hours
- +5 more secondary outcomes
Study Arms (1)
Oxygen Therapy
EXPERIMENTALOxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
Interventions
Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2021
First Posted
November 8, 2021
Study Start
October 18, 2021
Primary Completion
April 15, 2022
Study Completion
April 15, 2022
Last Updated
May 11, 2022
Record last verified: 2022-05