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NCT03883490

Role of Elastin Metabolites in Aortic Remodelling in AS

NCT ID: NCT03883490

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-27

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Aortic Stenosis

Keywords

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Magnetic Resonance Imaging Elastin Metabolites Aorta Stiffness Bicuspid aortic valve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bicuspid Aortic valve

Patients with a bicuspid aortic valve

ECG

Intervention Type DIAGNOSTIC_TEST

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

Blood test and biobanking

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Measurement of carotid-femoral PWV will be made using the Vicorder technique.

Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Tri-leaflet Aortic valve

Patients with a tri-leaflet aortic valve

ECG

Intervention Type DIAGNOSTIC_TEST

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

Blood test and biobanking

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Measurement of carotid-femoral PWV will be made using the Vicorder technique.

Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Interventions

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ECG

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Vicorder recording

Measurement of carotid-femoral PWV will be made using the Vicorder technique.

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Imaging

Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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0687

Identifier Type: -

Identifier Source: org_study_id