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Role of Elastin Metabolites in Aortic Remodelling in AS

NCT03883490 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2023-12-20

No results posted yet for this study

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

DIAGNOSTIC_TEST

ECG

A 12-lead ECG will be taken for each participant.

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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.

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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.

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883490 on ClinicalTrials.gov