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Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery - Trial NCT05696145

Access comprehensive clinical trial information for NCT05696145 through Pure Global AI's free database. This phase not specified trial is sponsored by Lisa Gundestrup and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 170 participants.

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NCT05696145
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Trial Details
ClinicalTrials.gov โ€ข NCT05696145
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Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors

Study Focus

Aortic Valve Stenosis

Observational

Sponsor & Location

Lisa Gundestrup

Odense University Hospital

Timeline & Enrollment

N/A

Mar 01, 2023

Jan 31, 2025

170 participants

Primary Outcome

Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients

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.

ICD-10 Classifications

Aortic (valve) stenosis
Aortic (valve) stenosis with insufficiency
Congenital stenosis of aortic valve
Stenosis of aorta
Rheumatic aortic stenosis

Data Source

ClinicalTrials.gov

NCT05696145

Non-Device Trial