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Clinical Trials/NCT05696145
NCT05696145Not yet recruitingNot Applicable

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

Lisa Gundestrup0 sites170 target enrollmentStarted: March 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
170
Primary Endpoint
Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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

Time Frame: At the time of surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Lisa Gundestrup
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lisa Gundestrup

MD.

Odense University Hospital

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Aortic Stenosis Associated Left... | Clinical Trial