Aortic Valve StenosisSAS-fibrosisNCT07331116
Echocardiography Findings in Patients With Myocardial Fibrosis and Severe 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.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Valve Stenosis, Myocardial Fibrosis
- What is being tested?
- Transthoracic echocardiography and Cardiac magnetic resonance imaging
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- 10 Apr 2014to 1 Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is retrospective. Study participants has been selected among patients on waiting list for aortic valve replacement at Ullevaal Hospital, Oslo, Norway. Ages between 18 and 80 years, with no known other cardiac condition that can cause myocardial fibrosis.
Who may be able to join
- Planned for aortic valve replacement for symptomatic, severe aortic stenosis
Who cannot join
- Previous myocardial infarction / coronary disease that can cause fibrosis
- Do not wish to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlations Between Biopsy Verified Myocardial Fibrosis and Echocardiography Parameters in Patients With 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.
Read the detailed description
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.
- Conditions
- Aortic Valve Stenosis, Myocardial Fibrosis
- Being tested
- Transthoracic echocardiography, Cardiac magnetic resonance imaging
- Keywords
- Myocardial fibrosis, Endomyocardial biopsy, Echocardiography, Aortic stenosis, Diastolic dysfunction
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Transthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure
Cardiac magnetic resonance imagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Aortic stenosis with biopsy-verified myocardial fibrosis | Periopererative echocardiography Receives: Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Cardiac magnetic resonance imaging | |
| Aortic stenosis without biopsy-verified myocardial fibrosis | Periopererative echocardiography Receives: Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography parameters of systolic and diastolic function
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)
Measured: 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.
Secondary outcomes (1)
CMR parameters of systolic and diastolic function
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
Measured: CMR was taken preoperatively, and at 1-year postoperative check-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Apr 2014
- Primary completion16 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Rikshospitalet University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331116
- Sponsor's protocol ID
- 2017/1068b
- Acronym
- SAS-fibrosis
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almaas VM, Haugaa KH, Strom EH, Scott H, Smith HJ, Dahl CP, Geiran OR, Endresen K, Aakhus S, Amlie JP, Edvardsen T. Noninvasive assessment of myocardial fibrosis in patients with obstructive hypertrophic cardiomyopathy. Heart. 2014 Apr;100(8):631-8. doi: 10.1136/heartjnl-2013-304923. Epub 2013 Dec 24.
PubMed 24368281
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Biopsy Verified Myocardial Fibrosis and Echocardiography Parameters in Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07331116
- Acronym / sponsor ID
- SAS-fibrosis / 2017/1068b
- Conditions
- Aortic Valve Stenosis, Myocardial Fibrosis
- Keywords
- Myocardial fibrosis, Endomyocardial biopsy, Echocardiography, Aortic stenosis, Diastolic dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Rikshospitalet University Hospital
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic stenosis with biopsy-verified myocardial fibrosis | – | Diagnostic Test: Transthoracic echocardiography, Diagnostic Test: Cardiac magnetic resonance imagingPeriopererative echocardiography |
| Aortic stenosis without biopsy-verified myocardial fibrosis | – | Diagnostic Test: Transthoracic echocardiography, Diagnostic Test: Cardiac magnetic resonance imagingPeriopererative echocardiography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is retrospective. Study participants has been selected among patients on waiting list for aortic valve replacement at Ullevaal Hospital, Oslo, Norway. Ages between 18 and 80 years, with no known other cardiac condition that can cause myocardial fibrosis.
Key inclusion criteria (1 listed)
- Planned for aortic valve replacement for symptomatic, severe aortic stenosis
Key exclusion criteria (2 listed)
- Previous myocardial infarction / coronary disease that can cause fibrosis
- Do not wish to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyTransthoracic echocardiography, performed close in time to the endomyocardial biopsy taken during aortic valve replacement procedure | Diagnostic test | Aortic stenosis with biopsy-verified myocardial fibrosis, Aortic stenosis without biopsy-verified myocardial fibrosis |
| Cardiac magnetic resonance imagingCardiac 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. | Diagnostic test | Aortic stenosis with biopsy-verified myocardial fibrosis, Aortic stenosis without biopsy-verified myocardial fibrosis |
Primary outcome
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)
1 secondary outcome
CMR parameters of systolic and diastolic function
Time frame: CMR was taken preoperatively, and at 1-year postoperative check-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 24368281Almaas VM, Haugaa KH, Strom EH, Scott H, Smith HJ, Dahl CP, Geiran OR, Endresen K, Aakhus S, Amlie JP, Edvardsen T. Noninvasive assessment of myocardial fibrosis in patients with obstructive hypertrophic cardiomyopathy. Heart. 2014 Apr;100(8):631-8. doi: 10.1136/heartjnl-2013-304923. Epub 2013 Dec 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 1 inclusion and 2 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 17 Apr 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?
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.). 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 NCT07331116, which also lists 1 linked publication.
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 17 Apr 2026.