Role of Elastin Metabolites in Aortic Remodelling in AS (ELASTIC-AS)

University of Leicester

Status

Completed

Conditions

Aortic Stenosis

Treatments

Diagnostic Test: ECG

Diagnostic Test: Blood test and biobanking

Diagnostic Test: Magnetic Resonance Imaging

Diagnostic Test: Vicorder recording

Diagnostic Test: Trans-thoracic Echocardiogram

Study type

Observational

Funder types

Other

Identifiers

NCT03883490

0687

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant is willing and able to give informed consent for participation in the study.
Age 18 years or above.
Planned surgical AVR (+/- CABG or aortic root surgery) for severe AS.
Ability to understand the written information in English.

Exclusion criteria

The participant may not enter the study if ANY of the following apply:

Contraindication to MRI (e.g., non-compatible pacemaker or other device).
Severe claustrophobia (unable to have MRI scan).
eGFR<30ml/min (contra-indication to have contrast agent during MRI).
Contraindication to Adenosine (severe asthma).
Significant arrhythmia.
Other valve disease > moderate in severity.
Female participants who are pregnant or lactating.
Previous aortic valve or aorta surgery, previous CABG or other surgery involving aortic cross clamping.
Participant in an interventional cardiovascular clinical trial.