Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04207593
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2019-12-17
Brief Title:
The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Prospective Randomized Controlled Trial of the Effect of Long-term Oxygen Therapy on 6-minute Walking Distance Clinical Parameters and Hemodynamics in Patients With PAH and CTEPH
Status:
COMPLETED
Status Verified Date:
2024-06
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:
SOPHA
Brief Summary:
Treatment of O2 naïve patients with PAH will be included in this investigator-initiated trial IIT to assess efficacy and safety of oxygen substitution Nocturnal oxygen substitution improved the 6MWD compared to placebo in one clinical trial in PAH patients Due to the positive results in the treatment of patients with PAH the initiation of this proof-of-concept study is justified
Detailed Description:
Most patients with PAH except those with congenital heart defects and pulmonary-to-systemic shunts have minor degrees of hypoxemia at rest and during the nightCurrent recommendations including the pneumological guidelines for LTOT are based on evidence in patients with chronic obstructive pulmonary disease as data for patients with PH are lacking When O2 partial pressure is repeatedly 8 kPa 60 mmHg alternatively 90 of O2 saturation patients are advised to use O2 to achieve a saturation of 8 kPa The use of ambulatory O2 can be considered when there is evidence of a symptomatic response or correction of exercise-induced desaturation
There are only few studies investigating the effect of oxygen supply in pulmonary hypertension most of which merely investigate acute effects of O2 administration Short-term oxygen administration has been shown to reduce mean pulmonary arterial pressure pulmonary vascular resistance and to increase cardiac output in PAH patients In one study oxygen supply also reversed the progression of PH in patients with chronic obstructive pulmonary disease COPD One recent randomized-controlled trial indicates that O2 given during cardiopulmonary exercise significantly improves maximal work rate and endurance Furthermore nocturnal oxygen supply for one week significantly improved 6-minute walking distance in patients with PH sleep-associated breathing difficulties exercise performance during the day as well as cardiac repolarisation Patients with Eisenmengers syndrome gain little benefit from nocturnal O2 therapy
Whether these positive effects of O2 supplementation during exercise would translate into long-term improvements of exercise capacity quality of life hemodynamics and disease progression is not known to date Up to now there are no randomised studies suggesting that long-term O2 therapy is indicated or when it should be initiated
There are only few studies investigating the effect of oxygen supply in pulmonary hypertension most of which merely investigate acute effects of O2 administration Short-term oxygen administration has been shown to reduce mean pulmonary arterial pressure pulmonary vascular resistance and to increase cardiac output in PAH patients In one study oxygen supply also reversed the progression of PH in patients with chronic obstructive pulmonary disease COPD One recent randomized-controlled trial indicates that O2 given during cardiopulmonary exercise significantly improves maximal work rate and endurance Furthermore nocturnal oxygen supply for one week significantly improved 6-minute walking distance in patients with PH sleep-associated breathing difficulties exercise performance during the day as well as cardiac repolarisation Patients with Eisenmengers syndrome gain little benefit from nocturnal O2 therapy
Whether these positive effects of O2 supplementation during exercise would translate into long-term improvements of exercise capacity quality of life hemodynamics and disease progression is not known to date Up to now there are no randomised studies suggesting that long-term O2 therapy is indicated or when it should be initiated
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?:
False
Is an FDA AA801 Violation?:
None