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Completed

NCT Number: NCT07331116

Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis

Patients with aortic stenosis waiting for aortic valve repair were investigated with echocardiography preoperatively, and a myocardial biospy was taken during the operation. The investigators aim to perform a retrospective analysis of these data, to look for correlations between biopsy-verified myocardial fibrosis and echocardiography parameters.

The patients also had cardiac magnetic resonance imaging performed, for a non-invasive quantification of myocardial fibrosis.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Myocardial Fibrosis Ventricular Outflow Obstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwegian University of Science and Technology

Trondheim, 7491, Norway

About this study

The primary purpose of the study is to retrospectively compare echocardiography measurements with a myocardial biopsy taken perioperatively in patients with aortic stenosis requiring aortic valve replacement.

Echocardiography and endomyocardial biopsy have been performed in close proximity in time. Due to a small sample size and a large number of echocardiography measurements being possible, only a limited number of prespecified comparisons are performed.

Cardiac magnetic resonance (CMR) was also performed in patients without contraindication, providing a non-invasive gold standard for diffuse fibrosis and replacement fibrosis. A secondary goal will be to investigate how echocardiography parameters performs compared to CMR in quantifying myocardial fibrosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned for aortic valve replacement for symptomatic, severe aortic stenosis

Exclusion criteria

  • Previous myocardial infarction / coronary disease that can cause fibrosis
  • Do not wish to participate in study

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

Transthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure

Cardiac magnetic resonance imaging

Diagnostic Test

Cardiac magnetic resonance imaging was taken on selected patients without contraindications. The CMR protocol was changed midway during study inclusions (May 2017), in order to better be able to quantify myocardial fibrosis.

Primary outcomes

  1. Echocardiography parameters of systolic and diastolic function

    Time frame: Time between echocardiography exam and endomyocardial biopsy was kept as short as possible, and not more than one month apart. If no cardiac event had happened in between, echocardiography and biopsy could be regarded as being taken at the same time.

    Echocardiograhic parameters on structure and function of the heart, as described in guidelines for echocardiography assessment:

    Basal hypertrophy of interventricular septum, in mm. LV end diastolic mass (preferably from 3D volume of LV) LV end diastolic mass, indexed (preferably from 3D volume of LV) Left ventricular global longitudinal strain (%) Left ventricular ejection fraction, 3D Left ventricular septal strain rate, peak systolic, sample placed in basal septum Grading of diastolic dysfunction (ref EACVI/ASE guidelines) Left atrial strain, reservoir function, biplane Left atrial strain, conduit function , biplane Left atrial strain, (atrial) contraction phase, biplane Severity of aortic stenosis, evaluated by echocardiography (mild, moderate, severe)

Secondary outcomes

  1. CMR parameters of systolic and diastolic function

    Time frame: CMR was taken preoperatively, and at 1-year postoperative check-up

    Left ventricular (LV) end diastolic volume, CMR LV end systolic volume, CMR LV stroke volume, CMR LV ejection fraction, CMR LV cardiac output, CMR LV cardiac index, CMR Global peak wall thickness, CMR CMR-dreived left ventricular mass, in end-diastole

    Left atrial volume in left atrial end systole, measured with CMR (left ventricular ED) Left atrial volume in left atrial end diastole, measured with CMR (left ventricular ES) Left atrial ejecton fraction, measured with CMR

    Global native T1 in myocardium, CMR Global post contrast T1 in myocardium, CMR Global ECV value in myocardium, CMR

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Rikshospitalet University Hospital

Registry information

Official study title

Correlations Between Biopsy Verified Myocardial Fibrosis and Echocardiography Parameters in Patients With Severe Aortic Stenosis

Acronym: SAS-fibrosis

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2026
Registry last updated
Apr 17, 2026

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.

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