Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03581851
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2018-06-20
Brief Title:
Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure
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:
2020-01
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 FIO2 151 equivalent to 2500m above sea level on ECG repolarizations and non-invasive blood pressure measurements by Finapres NOVA Technology
Detailed Description:
Low altitude baseline measurements will be performed in Zurich 469m asl including Echocardiography right heart catheterization six Minute Walking test 6MWT pulmonary function test clinical assessment and blood gas analysis at rest and under exercise Randomly assigned to the order of testing the participants will e tested under simulated altitude FiO2 151 with the AMC Altitrainer and shamed altitude with the same device During the exposure to simulated altitude FiO2 151 and shamed altitude of 1 hour each the participants ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected
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