Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01772758
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2012-10-16
Brief Title:
Cystic Fibrosis and Endothelial Function At Rest and During Exercise
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
Influence of Cystic Fibrosis on Vascular Endothelial Function at Rest and During Exercise
Status:
COMPLETED
Status Verified Date:
2019-06
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:
None
Brief Summary:
Perhaps one of the most disturbing aspects of Cystic Fibrosis CF is the associated premature death Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients with CF regardless of how healthy their lungs are A critical barrier to improving the quality of life and longevity in patients with CF is our lack of knowledge regarding the different reasons why patients with CF cannot exercise to the level of their peers We have collected preliminary data to support our central hypothesis that oxidative stress contributes to the impairment in blood vessel function at rest and during exercise which ultimately oxygen transport and delivery resulting in exercise intolerance Exercise is therapeutic medicine for patients with CF and this investigation represents a major breakthrough in the approach to begin understanding the physiological mechanisms which contribute to exercise intolerance in these patients
Detailed Description:
The overall goals of this proposal are to provide mechanistic evidence that oxidative stress contributes to 1 endothelial dysfunction and 2 exercise intolerance in patients with CF This study consists of two separate sub-studies or protocols Protocol 1 AOC tested the effect of an antioxidant cocktail AOC on endothelial function at rest and during exercise in CF patients Protocol 2 BH4 tested the effect of tetrahydrobiopterin BH4 on endothelial function at rest and during exercise in CF patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None