An observational study in Aortic Stenosis, Myocardial Fibrosis and Left Ventricular Hypertrophy, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by University of Edinburgh · Observational
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's enrollment of 90 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred for surgery for aortic valve disease (aortic stenosis group) and those referred for non-aortic valve cardiac surgery or elective ascending aorta surgery (control group)
Inclusion Criteria (control group):
Exclusion Criteria (aortic stenosis group):
Exclusion Criteria (control group):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery
Patients scheduled to undergo non-aortic valve cardiac or elective ascending aortic surgery
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)
Time frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
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)
Time frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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