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

NCT05696145 | Unknown

• 1 other identifier: SALVAGE protocol version 1
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

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:

• Cardiac ultrasound, MR- and CT-scan prior to surgery
• Blooddraw prior to surgery.
• Heartmuscle biopsy during surgery
• Cardiac MR-scan 1 year after surgery.

Conditions

Aortic Valve Stenosis

Keywords

low flow low gradient aortic valve stenosis

Outcome Measures

Primary Outcomes (1)

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

  At the time of surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred for surgical aortic valve replacement at the department of Cardiothoracic and vascular surgery at Odense University Hospital, Denmark will be evaluated and if they meet the inclusion criteria they will be invited to participate in the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lisa Gundestrup: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples + myocardial biopsy

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Lisa Gundestrup, MD

CONTACT

+4530563464; lisa.gundestrup@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share