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

Aortic Valve Stenosis Clinical Trial

— SALVAGE  

Official title:

Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696145
• Other study ID #: SALVAGE protocol version 1
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2023
• Source: Odense University Hospital
• Contact: Lisa Gundestrup, MD
• Phone: +4530563464
• Email: lisa.gundestrup[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Ventricular Remodeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lisa Gundestrup

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients		At the time of surgery