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Mechanism of Decompensation Evaluation - Aortic Stenosis (MODE-AS)

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ClinicalTrials.gov Identifier: NCT03332745
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Russell Everett, University of Edinburgh

Brief Summary:

Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. The pathological processes in the left ventricle that ultimately result in heart failure and death are incompletely understood. Further elucidation of these processes and how they correlate with novel blood biomarkers may help us design new treatments and optimise the timing of surgical intervention.

In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve replacement surgery will be invited for some simple tests (blood sampling, ECG, echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the disease valve retained. These will be examined histologically and pathological changes compared with results obtained from ECG, echocardiogram and blood tests.


Condition or disease
Aortic Stenosis Myocardial Fibrosis Left Ventricular Hypertrophy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis
Estimated Study Start Date : November 15, 2017
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort
Severe aortic stenosis
Patients with severe aortic stenosis who are scheduled to undergo aortic valve replacement surgery
Control group
Patients scheduled to undergo non-aortic valve cardiac or elective ascending aortic surgery



Primary Outcome Measures :
  1. Correlation of blood biomarkers with pathological changes on myocardial biopsy [ Time Frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy) ]
    Correlation between biomarkers (e.g. high sensitivity troponin I, BNP) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)


Secondary Outcome Measures :
  1. Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy [ Time Frame: Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy) ]
    Correlation between imaging measures (e.g. LV diastolic function, longitudinal systolic function, ECG LVH criteria, ECG strain pattern) with levels of myocardial fibrosis (collagen volume fraction as measured by picrosirius red staining)


Biospecimen Retention:   Samples With DNA
Serum and plasma samples Myocardial biopsy specimens Aortic valve tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for surgery for aortic valve disease (aortic stenosis group) and those referred for non-aortic valve cardiac surgery or elective ascending aorta surgery (control group)
Criteria
  • Inclusion Criteria (aortic stenosis group):
  • Age over 18
  • Severe aortic stenosis with planned aortic valve replacement

Inclusion Criteria (control group):

  • Age over 18
  • Planned non-aortic valve cardiac or elective ascending aorta surgery

Exclusion Criteria (aortic stenosis group):

  • Coexistent severe aortic or mitral regurgitation
  • Coexistent mitral stenosis greater than mild in severity
  • Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
  • Acute pulmonary oedema or cardiogenic shock
  • Coexistent hypertrophic cardiomyopathy
  • Unable to give informed consent

Exclusion Criteria (control group):

  • Significant aortic valve disease (mild aortic stenosis / regurgitation or greater)
  • Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis)
  • Acute pulmonary oedema or cardiogenic shock
  • Coexistent hypertrophic cardiomyopathy
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332745


Contacts
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Contact: Russell J Everett, MBBS 01312426361 russell.everett@ed.ac.uk

Locations
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United Kingdom
University of Edinburgh / NHS Lothian Recruiting
Edinburgh, Midlothian, United Kingdom, EH164SB
Contact: Russell J Everett, MBBS    01312426361    russell.everett@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Russell J Everett, MBBS University of Edinburgh

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Responsible Party: Russell Everett, Clinical Research Fellow, University of Edinburgh
ClinicalTrials.gov Identifier: NCT03332745     History of Changes
Other Study ID Numbers: E161633
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Russell Everett, University of Edinburgh:
Troponin

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Hypertrophy
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cardiomegaly