Role of Elastin Metabolites in Aortic Remodelling in AS

Completed

• Conditions: Aortic Stenosis
• Interventions: Diagnostic Test: ECG; Diagnostic Test: Blood test and biobanking; Diagnostic Test: Trans-thoracic Echocardiogram; Diagnostic Test: Vicorder recording; Diagnostic Test: Magnetic Resonance Imaging

• Registration Number: NCT03883490
• Lead Sponsor: University of Leicester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-21
• Study Start: 2019-06-27
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bicuspid Aortic valve	ECG	Patients with a bicuspid aortic valve
Tri-leaflet Aortic valve	Trans-thoracic Echocardiogram	Patients with a tri-leaflet aortic valve
Tri-leaflet Aortic valve	Vicorder recording	Patients with a tri-leaflet aortic valve
Tri-leaflet Aortic valve	ECG	Patients with a tri-leaflet aortic valve
Bicuspid Aortic valve	Magnetic Resonance Imaging	Patients with a bicuspid aortic valve
Bicuspid Aortic valve	Blood test and biobanking	Patients with a bicuspid aortic valve
Bicuspid Aortic valve	Trans-thoracic Echocardiogram	Patients with a bicuspid aortic valve
Bicuspid Aortic valve	Vicorder recording	Patients with a bicuspid aortic valve
Tri-leaflet Aortic valve	Blood test and biobanking	Patients with a tri-leaflet aortic valve
Tri-leaflet Aortic valve	Magnetic Resonance Imaging	Patients with a tri-leaflet aortic valve

Primary Outcome Measures

Name	Time	Method
Levels of metabolites of elastin turnover	12 months	Change in levels of metabolites of elastin turnover pre- and post-AVR.

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (LVEF) on MRI	12 months	LVEF measured on MRI (measures of cardiac function) pre- and post-AVR.
Left ventricular mass index (LVMI) on MRI	12 months	LVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR.
Aortic distensibility on MRI	12 months	Aortic distensibility measured on MRI pre- and post-AVR.
Pulse wave velocity on MRI	12 months	Pulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR.

Trial Locations

Locations (1)

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom