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NCT05696145 | Not yet recruiting | Aortic Valve Stenosis

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

Information provided by (Responsible Party):

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: 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. Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system. 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.

Condition or disease

Aortic Valve Stenosis

Study Type : Observational
Estimated Enrollment : 170 participants
Official Title : Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 31, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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)
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery

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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

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