Mechanism of Decompensation Evaluation - Aortic Stenosis

NCT03332745 | Completed

• 1 other identifier: E161633
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Myocardial Fibrosis; Left Ventricular Hypertrophy

Keywords

Troponin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsy

  Biomarkers collected within 1 month prior to date of surgery (and myocardial biopsy)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Age over 18
• Severe aortic stenosis with planned aortic valve replacement
• Age over 18
• Planned non-aortic valve cardiac or elective ascending aorta surgery

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh / NHS Lothian

Edinburgh, Midlothian, EH164SB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma samples Myocardial biopsy specimens Aortic valve tissue

MeSH Terms

Conditions

Aortic Valve Stenosis; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell J Everett, MBBS

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: September 3, 2018
• Primary Completion: August 12, 2021
• Study Completion: July 31, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

GB (1)