Mechanism of Decompensation Evaluation – Aortic Stenosis

Overview

Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. The pathological processes in the left ventricle that ultimately result in heart failure and death are incompletely understood. Further elucidation of these processes and how they correlate with novel blood biomarkers may help us design new treatments and optimise the timing of surgical intervention. In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve replacement surgery will be invited for some simple tests (blood sampling, ECG, echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the disease valve retained. These will be examined histologically and pathological changes compared with results obtained from ECG, echocardiogram and blood tests.

Full Title of Study: “Mechanism of Left Ventricular Decompensation Evaluation – Aortic Stenosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 15, 2021

Arms, Groups and Cohorts

  • Severe aortic stenosis
    • Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery
  • Control group
    • Patients scheduled to undergo non-aortic valve cardiac or elective ascending aortic surgery

Clinical Trial Outcome Measures

Primary Measures

  • Correlation of blood biomarkers with pathological changes on myocardial biopsy
    • Time Frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
    • Correlation between biomarkers (e.g. high sensitivity troponin I, BNP) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)

Secondary Measures

  • Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy
    • Time Frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
    • Correlation between imaging measures (e.g. LV diastolic function, longitudinal systolic function, ECG LVH criteria, ECG strain pattern) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)

Participating in This Clinical Trial

Inclusion Criteria (aortic stenosis group):

  • Age over 18 – Severe aortic stenosis with planned aortic valve replacement Inclusion Criteria (control group): – Age over 18 – Planned non-aortic valve cardiac or elective ascending aorta surgery Exclusion Criteria (aortic stenosis group): – Coexistent severe aortic or mitral regurgitation – Coexistent mitral stenosis greater than mild in severity – Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) – Acute pulmonary oedema or cardiogenic shock – Coexistent hypertrophic cardiomyopathy – Unable to give informed consent Exclusion Criteria (control group): – Significant aortic valve disease (mild aortic stenosis / regurgitation or greater) – Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) – Acute pulmonary oedema or cardiogenic shock – Coexistent hypertrophic cardiomyopathy – Unable to give informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Edinburgh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Russell Everett, Clinical Research Fellow – University of Edinburgh
  • Overall Official(s)
    • Russell J Everett, MBBS, Principal Investigator, University of Edinburgh
  • Overall Contact(s)
    • Russell J Everett, MBBS, 01312426361, russell.everett@ed.ac.uk

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