Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03592927
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2018-07-09
Brief Title:
Acute Exposure to Simulated Hypoxia on Exercise Capacity
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension Physiological and Clinical Effects at Rest and During Exercise
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized crossover trial in patients with Pulmonary Hypertension PAH CTEPH to assess the acute response to simulated altitude FiO2151 equivalent to 2500m above sea level in constant loaded exercise capacity
Detailed Description:
Low altitude baseline measurements will be performed in Zurich 460m asl including Echocardiography Right heart catheterization six-minute walk test 6MWT pulmonary function test clinical assessment and blood gas Analysis
Randomly assigned to the order of testing the participants will be tested under simulated altitude FiO2 151 with the AMC Altitrainer and shamed altitude with the same device
Towards the end of the exposure after approximately 1h the participants will perform a constant loaded exercise test on an Ergometer with a calculated resistance of their 60 max workload
The patients will be encouraged to perform this test up to their physical exhaustion
Randomly assigned to the order of testing the participants will be tested under simulated altitude FiO2 151 with the AMC Altitrainer and shamed altitude with the same device
Towards the end of the exposure after approximately 1h the participants will perform a constant loaded exercise test on an Ergometer with a calculated resistance of their 60 max workload
The patients will be encouraged to perform this test up to their physical exhaustion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None