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Mechanism of Decompensation Evaluation - Aortic Stenosis

Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03332745
Acronym
MODE-AS
Enrollment
90
Registered
2017-11-06
Start date
2018-09-03
Completion date
2023-07-31
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Left Ventricular Hypertrophy, Myocardial Fibrosis

Keywords

Troponin

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.

Interventions

None listed

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of blood biomarkers with pathological changes on myocardial biopsyBiomarkers 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

MeasureTime frameDescription
Correlation of echocardiographic and ECG measures with pathological changes on myocardial biopsyBiomarkers 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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026