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SALVAGE: 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 (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696145
Collaborator
(none)
170
Enrollment
23.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    170 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Jan 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients [At the time of surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lisa Gundestrup

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lisa Gundestrup, MD., Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT05696145
    Other Study ID Numbers:
    • SALVAGE protocol version 1
    First Posted:
    Jan 25, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lisa Gundestrup, MD., Odense University Hospital
    low flow low gradient aortic valve stenosis
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Constriction, Pathologic
    Ventricular Remodeling

    Study Results

    No Results Posted as of Jan 25, 2023