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

Not yet recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT05696145
• Lead Sponsor: Lisa Gundestrup

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25
• Study Start: 2023-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Severe AS (estimated by the local heart team, aortic valve area<1cm2) referred for AVR at the cardiology department at Odense University Hospital
2. Age > 18 years
3. Signed informed consent

Exclusion Criteria

1. Bicuspid aortic valve.
2. LV systolic dysfunction (LVEF<50%).
3. Patients with concomitant moderate-severe aortic valve regurgitation.
4. Concomitant moderate-severe mitral valve regurgitation.
5. Moderate to severe nephropathy (s-creatinine >200 mmol/l)
6. Unwilling to participate in the study.
7. Claustrophobia.
8. Permanent cardiac devices (pacemaker and ICD)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients	At the time of surgery