Skip to main content
OpenTrials
Completed

NCT Number: NCT03332745

Mechanism of Decompensation Evaluation - Aortic Stenosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertrophy Hypertrophy, Left Ventricular Left Ventricular Hypertrophy Myocardial Fibrosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Edinburgh / NHS Lothian

Edinburgh, Midlothian, EH164SB, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

  • 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Mechanism of Left Ventricular Decompensation Evaluation - Aortic Stenosis

Acronym: MODE-AS

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Nov 6, 2017
Registry last updated
May 13, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.