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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03332745
Other study ID # E161633
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2018
Est. completion date July 31, 2023

Study information

Verified date May 2024
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 31, 2023
Est. primary completion date August 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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

Study Design


Locations

Country Name City State
United Kingdom University of Edinburgh / NHS Lothian Edinburgh Midlothian

Sponsors (1)

Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of blood biomarkers with pathological changes on 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) Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
Secondary Correlation of echocardiographic and ECG measures with pathological changes on 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) Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
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