Role of Elastin Metabolites in Aortic Remodelling in AS

Aortic Stenosis Clinical Trial

— ELASTIC-AS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883490
• Other study ID #: 0687
• Status: Completed
• Start date: June 27, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Diagnostic Test:
• ECG
A 12-lead ECG will be taken for each participant.
• 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.
• 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.
• Vicorder recording
Measurement of carotid-femoral PWV will be made using the Vicorder technique.
• Magnetic Resonance Imaging
Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of metabolites of elastin turnover	Change in levels of metabolites of elastin turnover pre- and post-AVR.	12 months
Secondary	Aortic distensibility on MRI	Aortic distensibility measured on MRI pre- and post-AVR.	12 months
Secondary	Pulse wave velocity on MRI	Pulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR.	12 months
Secondary	Left ventricular mass index (LVMI) on MRI	LVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR.	12 months
Secondary	Left ventricular ejection fraction (LVEF) on MRI	LVEF measured on MRI (measures of cardiac function) pre- and post-AVR.	12 months