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Clinical Trials/NCT03332745
NCT03332745
Completed
Not Applicable

Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis

University of Edinburgh1 site in 1 country90 target enrollmentSeptember 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Stenosis
Sponsor
University of Edinburgh
Enrollment
90
Locations
1
Primary Endpoint
Correlation of blood biomarkers with pathological changes on myocardial biopsy
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 3, 2018
End Date
July 31, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy(Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy))

Study Sites (1)

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