Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05600062
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2022-10-03
Brief Title:
Influence of NEP Inhibition on Vascular Leak and Inflammation NEPi-INFLAMMATION
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Assessment of the Effect of Neutral Endopeptidase Inhibition on Vascular Leak and Leukocyte Accumulation in a Human Cantharidin Blister Model
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Acute Respiratory Distress Syndrome ARDS is a severe type of lung injury that affects 10 of patients admitted to Intensive Care Units worldwide with an unacceptably high mortality of up to 48 in those with the most severe form of the condition It is a complex and poorly understood syndrome that results in progressive failure of the lungs Crucially the inflamed lungs allow fluid to leak from the circulation into the airspace so that patients lungs fill with fluid - drowning from the inside As this condition progresses the patient typically requires increasing amounts of oxygen and eventually support from a ventilator To date there are no effective treatments for ARDS that can limit stop or repair this process
This research study is aiming to look at a naturally occurring substance produced by blood vessels C-type natriuretic peptide CNP The investigators have evidence suggesting that CNP plays a role in maintaining the barrier provided by blood vessels that stops fluid leaking out into tissues This is based on various studies done on CNP by the investigators research group that have established its widespread role in maintaining cells that line blood vessels and play a vital role in lungs barrier function the endothelium
CNP is broken down in part by an enzyme called Neutral endopeptidase and therefore drugs that inhibit this enzyme would result in increased CNP concentration and activity If CNP does in fact strengthen the lungs endothelial barrier then this class of drug may benefit patients with ARDS The aim of this experimental medicine study is to assess the effect of using the licensed NEP inhibitor Racecadotril in a well-established safe model of inflammation-induced skin blisters in healthy human volunteers to determine primarily whether the fluid accumulation ie leak in these blisters is reduced by treatment with this drug
This research study is aiming to look at a naturally occurring substance produced by blood vessels C-type natriuretic peptide CNP The investigators have evidence suggesting that CNP plays a role in maintaining the barrier provided by blood vessels that stops fluid leaking out into tissues This is based on various studies done on CNP by the investigators research group that have established its widespread role in maintaining cells that line blood vessels and play a vital role in lungs barrier function the endothelium
CNP is broken down in part by an enzyme called Neutral endopeptidase and therefore drugs that inhibit this enzyme would result in increased CNP concentration and activity If CNP does in fact strengthen the lungs endothelial barrier then this class of drug may benefit patients with ARDS The aim of this experimental medicine study is to assess the effect of using the licensed NEP inhibitor Racecadotril in a well-established safe model of inflammation-induced skin blisters in healthy human volunteers to determine primarily whether the fluid accumulation ie leak in these blisters is reduced by treatment with this drug
Detailed Description:
None
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