NCT03883490

Role of Elastin Metabolites in Aortic Remodelling in AS

A Pilot Study of ELastin Metabolites and Aortic Remodelling Following Surgery for Tricuspid and bICuspid Aortic Stenosis (ELASTIC-AS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ECG	A 12-lead ECG will be taken for each participant.
DIAGNOSTIC_TEST	Blood test and biobanking	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.
DIAGNOSTIC_TEST	Trans-thoracic Echocardiogram	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.
DIAGNOSTIC_TEST	Vicorder recording	Measurement of carotid-femoral PWV will be made using the Vicorder technique.
DIAGNOSTIC_TEST	Magnetic Resonance Imaging	Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Timeline

• Start date: 2019-06-27
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2019-03-21
• Last updated: 2023-12-20

Locations

1 site across 1 country: United Kingdom