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Enrolling by Invitation

NCT Number: NCT06571175

Quantification of Myocardial Fibrosis in Aortis Stenosis

This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.

Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Olavs Hosptial

Trondheim, Trøndelag, 7030, Norway

About this study

High frame rate ultrasound with quantification of myocardial mechanical wave velocities provides a new approach to evaluation of myocardial stiffness.

Principle: An elastic medium (the left ventricle) is incited by a force (naturally occuring mechanical wave generated by atrial contraction and/or closure of mitral and aortic valve), and the resulting oscillation wave propagates through the medium with a speed that depends only on the density and stiffness of the medium. If the density of the medium is known, measuring the propagation velocity of the wave is the same as measuring the stiffness of the medium.

There is a lack of longitudinal data in this research area. A follow-up study of the described cohort, will add valuable insight into high frame rate ultrasound as a potential tool to quantify myocardial fibrosis in heart failure patient, and to monitor any changes from baseline.

Who can participate

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

Inclusion criteria

  • Part of the initial cohort that were included in the baseline study
  • Still able to undergo protocolled investigations
  • Patients: Mild, moderate or severe AS

Exclusion criteria

  • Renal insufficiency
  • Previously myocardial infarction (ECG, echocardiogram or hospital record)
  • Severe valvular heart disease (except patients)
  • Other cardiac disease known to cause myocardial fibrosis
  • Severe hypertension
  • Other medical conditions deterring protocolled investigation and follow-up
  • Other medical conditions affecting 5-years prognosis (cancer, pulmonary disease)
  • Severely reduced image-quality (echocardiography and MRI)

Treatment and study plan

High frame rate echocardiography

Diagnostic Test

Conventional transthoracic echocardiography will be performed, with added 3D-imaging and acquisitions with high frame rate. The data from these patients will be anonymized and transferred for post-hoc analysis in dedicated computer software (GE Vingmed, EchoPac 2.6) and in validated machine learning algorithms.

Other names: GE Vingmed ultrasound scanner E95, 2017

MRI

Diagnostic Test

Cardiac MRI will be performed. In all patients without contraindications, a gadolinium-based contrast agent will be given.

Other names: Cardiac magnetic resonance imaging (CMRI)

Blood test

Diagnostic Test

Conventional brachial venous blood samples will be drawn. Hematocrit value {in %} will be used to calculate CMR-derived exttracellular volume (ECV)

ECG and Holter-ECG

Diagnostic Test

ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.

6 min walking test

Diagnostic Test

6 MWT will be performed, and the findings will be related to findings from CMRI/echocardiography.

Primary outcomes

  1. Cardiovascular morbidity

    Time frame: 5 year

    Admissions with heart failure

  2. Cardiovascular mortality

    Time frame: 5 year

    Death caused by cardiac disease

Secondary outcomes

  1. All cause mortality

    Time frame: 5 years

    Mortality in general

  2. Time of first re-hospitalization

    Time frame: 5 years

    Time of first re-hospitalization after inclusion

  3. Cardiac systolic function

    Time frame: 5 years

    Systolic function based on left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS).

    Unit of measure for LVEF and for GLS is % for both (a positive number for LVEF, and a negative number for GLS)

  4. Cardiac diastolic function (1 of 5)

    Time frame: 5 years

    Echocardiographic diastolic function based on i) left atrial volume index {ml/m^2).

  5. Cardiac diastolic function (2 of 5)

    Time frame: 5 years

    Echocardiographic diastolic function based on ii) mitral annular velocities {cm/sec}

  6. Cardiac diastolic function (3 of 5)

    Time frame: 5 years

    Echocardiographic diastolic function based on iii) mitral inflow velocities {cm/sec}

  7. Cardiac diastolic function (4 of 5)

    Time frame: 5 years

    Echocardiographic diastolic function based on iv) ricuspid regurgitation velocity {cm/sec}

  8. Cardiac diastolic function (5 of 5)

    Time frame: 5 years

    Echocardiographic diastolic function based on v) E/è-ratio

  9. Velocity of natural mechanical waves propagating through the myocardium

    Time frame: 5 years

    Investigate for prognotisc value and if it can be a marker of diastolic dysfunction. Unit of velocity measurement is m/sec.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

Myocardial Fibrosis With High Frame Rate Echocardiography in Patients With Aortic Stenosis - A Follow-up Study

Acronym: SAS-F-5

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Aug 7, 2025

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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