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Aortic Valve StenosisSAS-F-5NCT06571175

Quantification of Myocardial Fibrosis in Aortic Stenosis

An observational study of Aortic Valve Stenosis and Myocardial Fibrosis, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Aortic Valve Stenosis, Myocardial Fibrosis
What is being tested?
High frame rate echocardiography, MRI and Blood test
How many people
79 participants
Where
1 siteNorway
Study dates
21 Jan 2025to 14 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Adult, Older adult

Study population: Patients: Mild, moderate, or severe aortic valve stenosis. A subset of the patients will have undergone aortic valve replacement since inclusion. Controls: Healthy with no valve disease, or other cardiac disease known to cause myocardial fibrosis

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • St. Olavs Hosptial

    Trondheim, Trøndelag, 7030

Other trials in Norway

About this study

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

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.

Read the detailed description

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.

Being tested
High frame rate echocardiography, MRI, Blood test, ECG and Holter-ECG, 6 min walking test
Keywords
High frame rate echocardiography, Heart failure, Aortic stenosis, Cardiac MRI, Prognosis, Quantification of severity
Medical subject headings
Aortic Valve Stenosis, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High frame rate echocardiographyDiagnostic test

    Also called GE Vingmed ultrasound scanner E95, 2017

    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.

  • MRIDiagnostic test

    Also called Cardiac magnetic resonance imaging (CMRI)

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

  • Blood testDiagnostic 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-ECGDiagnostic test

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

  • 6 min walking testDiagnostic test

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

Study groups in NCT06571175
Study groupRoleWhat they receive
Aortic stenosisMild aortic stenosis:25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Moderate aortic stenosis: 25 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. Severe aortic stenosis: 50 patients were included at baseline, and those that still avoid exclusion criteria, will be invited to undergo repeat echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG.
Receives: Diagnostic Test: High frame rate echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test
ControlsThe controls from baseline inclusion will be invited to undergo repeat echocardiography, blood test and CMRI
Receives: Diagnostic Test: High frame rate echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular morbidity

    Admissions with heart failure

    Measured: 5 year

  2. Cardiovascular mortality

    Death caused by cardiac disease

    Measured: 5 year

Secondary outcomes (9)

  1. All cause mortality

    Mortality in general

    Measured: 5 years

  2. Time of first re-hospitalization

    Time of first re-hospitalization after inclusion

    Measured: 5 years

  3. Cardiac systolic function

    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)

    Measured: 5 years

  4. Cardiac diastolic function (1 of 5)

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

    Measured: 5 years

  5. Cardiac diastolic function (2 of 5)

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

    Measured: 5 years

  6. Cardiac diastolic function (3 of 5)

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

    Measured: 5 years

  7. Cardiac diastolic function (4 of 5)

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

    Measured: 5 years

  8. Cardiac diastolic function (5 of 5)

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

    Measured: 5 years

  9. Velocity of natural mechanical waves propagating through the myocardium

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start21 Jan 2025
  3. Primary completion1 Jun 2026
  4. Study completion14 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571175
Sponsor's protocol ID
527717
Acronym
SAS-F-5
Status last verified
Oct 2026
First submitted
10 Jul 2024
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Salles S, Espeland T, Molares A, Aase SA, Hammer TA, Stoylen A, Aakhus S, Lovstakken L, Torp H. 3D Myocardial Mechanical Wave Measurements: Toward In Vivo 3D Myocardial Elasticity Mapping. JACC Cardiovasc Imaging. 2021 Aug;14(8):1495-1505. doi: 10.1016/j.jcmg.2020.05.037. Epub 2020 Aug 26.

    PubMed 32861651

  • M. Mohajery, S. Salles, T. Espeland, S. Fadnes and L. Lovstakken,

  • Espeland T, Wigen MS, Dalen H, Berg EAR, Hammer TA, Salles S, Lovstakken L, Amundsen BH, Aakhus S. Mechanical Wave Velocities in Left Ventricular Walls in Healthy Subjects and Patients With Aortic Stenosis. JACC Cardiovasc Imaging. 2024 Feb;17(2):111-124. doi: 10.1016/j.jcmg.2023.07.009. Epub 2023 Sep 6.

    PubMed 37676209

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis and Myocardial Fibrosis, run by Norwegian University of Science and Technology at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular morbidity (time frame: 5 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06571175, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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