Mechanism of Decompensation Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-03

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Stenosis Myocardial Fibrosis Left Ventricular Hypertrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe aortic stenosis

Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery

No interventions assigned to this group

Control group

Patients scheduled to undergo non-aortic valve cardiac or elective ascending aortic surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age over 18
* Severe aortic stenosis with planned aortic valve replacement

* Age over 18
* Planned non-aortic valve cardiac or elective ascending aorta surgery

Exclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No