Brief Title
Mechanism of Decompensation Evaluation - Aortic Stenosis
Official Title
Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis
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.
Study Type
Observational
Primary Outcome
Correlation of blood biomarkers with pathological changes on myocardial biopsy
Secondary Outcome
Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy
Condition
Aortic Stenosis
Study Arms / Comparison Groups
Severe aortic stenosis
Description: Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
November 15, 2017
Completion Date
November 15, 2021
Primary Completion Date
November 15, 2021
Eligibility Criteria
- 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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Russell J Everett, MBBS, 01312426361, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03332745
Organization ID
E161633
Responsible Party
Principal Investigator
Study Sponsor
University of Edinburgh
Study Sponsor
Russell J Everett, MBBS, Principal Investigator, University of Edinburgh
Verification Date
November 2017