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NCT Number: NCT03883490

Role of Elastin Metabolites in Aortic Remodelling in AS

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECG

Diagnostic Test

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

Blood test and biobanking

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

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

Diagnostic Test

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

Magnetic Resonance Imaging

Diagnostic Test

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

Primary outcomes

  1. Levels of metabolites of elastin turnover

    Time frame: 12 months

    Change in levels of metabolites of elastin turnover pre- and post-AVR.

Secondary outcomes

  1. Aortic distensibility on MRI

    Time frame: 12 months

    Aortic distensibility measured on MRI pre- and post-AVR.

  2. Pulse wave velocity on MRI

    Time frame: 12 months

    Pulse wave velocity (measure of aortic stiffness) measured on MRI pre- and post-AVR.

  3. Left ventricular mass index (LVMI) on MRI

    Time frame: 12 months

    LVMI measured on MRI (measures of cardiac remodelling) pre- and post-AVR.

  4. Left ventricular ejection fraction (LVEF) on MRI

    Time frame: 12 months

    LVEF measured on MRI (measures of cardiac function) pre- and post-AVR.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Official study title

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

Acronym: ELASTIC-AS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2019
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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