Mechanism of Decompensation Evaluation - Aortic Stenosis

Aortic Stenosis Clinical Trial

— MODE-AS  

Official title:

Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03332745
• Other study ID #: E161633
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2017
• Last updated: November 1, 2017
• Start date: November 15, 2017
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2017
• Source: University of Edinburgh
• Contact: Russell J Everett, MBBS
• Phone: 01312426361
• Email: russell.everett[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy
• Myocardial Fibrosis

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh / NHS Lothian	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of blood biomarkers with pathological changes on 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)	Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)
Secondary	Correlation of echocardiographic and ECG measures with pathological changes on 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)	Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)