Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696145
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-25
First Post:
2023-01-13
Brief Title:
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
Sponsor:
Lisa Gundestrup
Organization:
Odense University Hospital
Study Overview
Official Title:
Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic Valvular and Non-valvular Factors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
SALVAGE
Brief Summary:
The goal of this study is to investigate the genetic and gender specific differences in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis Patients referred for surgical aorticvalve replacement will be offered to participarte in the study
The main questions the study aims to answer are
1 Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase Angiotensin-II ACE ACE2 and Angiotensin receptor 1 and 2
2 Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system
3 Gender differences in LV remodelling associates with different levels of sexual hormones
Patients participating in the study will be asked to undergo
Cardiac ultrasound MR- and CT-scan prior to surgery
Blooddraw prior to surgery
Heartmuscle biopsy during surgery
Cardiac MR-scan 1 year after surgery
The main questions the study aims to answer are
1 Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase Angiotensin-II ACE ACE2 and Angiotensin receptor 1 and 2
2 Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system
3 Gender differences in LV remodelling associates with different levels of sexual hormones
Patients participating in the study will be asked to undergo
Cardiac ultrasound MR- and CT-scan prior to surgery
Blooddraw prior to surgery
Heartmuscle biopsy during surgery
Cardiac MR-scan 1 year after surgery
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