Mechanism of Decompensation Evaluation - Aortic Stenosis

Completed

• Conditions: Left Ventricular Hypertrophy; Aortic Stenosis; Myocardial Fibrosis

• Registration Number: NCT03332745
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2018-09-03
• Primary Completion: 2021-08-12
• Study Completion: 2023-07-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of blood biomarkers with pathological changes on myocardial biopsy	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 Outcome Measures

Name	Time	Method
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)	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)

Trial Locations

Locations (1)

University of Edinburgh / NHS Lothian; 🇬🇧 Edinburgh, Midlothian, United Kingdom