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Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. It is also more common for them to develop enlargement of the main blood vessel coming out of the heart, the aorta, and some studies suggest that they are also at higher risk of life-threatening tears in the aortic wall. Current guidelines recommend surgical replacement of the aorta at an earlier stage in these patients. The exact mechanism for the dilatation is not clear, and some studies have suggested greater 'stiffness' in the wall of the aorta. In this study, the investigators propose to 1.) study aortic size, stiffness and flow patterns using MRI in patients with bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in patients' blood that may be important in the process of expansion, 3.) compare the change in MRI and blood markers at before and 12 months after surgery, in patients who are due to have aortic valve replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bicuspid Aortic valve | Patients with a bicuspid aortic valve |
| |
| Tri-leaflet Aortic valve | Patients with a tri-leaflet aortic valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG | Diagnostic Test | A 12-lead ECG will be taken for each participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levels of metabolites of elastin turnover | Change in levels of metabolites of elastin turnover pre- and post-AVR. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic distensibility on MRI | Aortic distensibility measured on MRI pre- and post-AVR. | 12 months |
| Pulse wave velocity on MRI | Pulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR. |
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Inclusion Criteria:
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
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Adult patients listed for a surgical aortic valve replacement (with or without coronary artery bypass graft) for severe aortic stenosis of bicuspid (n=15) and tri-leaflet (n=15) aortic valves will be potentially eligible to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000082882 | Bicuspid Aortic Valve Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006403 | Hematologic Tests |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Patient's plasma will be collected and stored for measurement of elastin metabolites and other biomarkers.
| Blood test and biobanking | Diagnostic Test | All patients will undergo venepuncture and blood sample will be taken for full blood count, renal function and plasma will be stored for future biomarker analysis. |
|
| Trans-thoracic Echocardiogram | Diagnostic Test | A standard TTE will be undertaken to measure severity of AS as well as bi-ventricular function. Speckle-tracking data will be performed offline to assess diastolic function. |
|
| Vicorder recording | Diagnostic Test | Measurement of carotid-femoral PWV will be made using the Vicorder technique. |
|
| Magnetic Resonance Imaging | Diagnostic Test | Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow. |
|
| 12 months |
| Left ventricular mass index (LVMI) on MRI | LVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR. | 12 months |
| Left ventricular ejection fraction (LVEF) on MRI | LVEF measured on MRI (measures of cardiac function) pre- and post-AVR. | 12 months |
| D014694 |
| Ventricular Outflow Obstruction |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004568 | Electrodiagnosis |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |