Aortic Valve StenosisNCT03422770

Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis

A study testing Echocardiography, MRI and Blood test in people with 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

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Aortic Valve Stenosis, Myocardial Fibrosis
What is being tested?: Echocardiography, MRI and Blood test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 1 siteNorway
Study dates: 9 Jan 2018to 30 Jun 2020
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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-yrs prognosis (cancer, pulmonary disease)
Severely reduced image-quality (echocardiography and MRI)

Trial locations and contacts

1 site in 1 country.

Norway1 site

Department of Circulation and Medical Imaging
Trondheim

Other trials in Norway

About this study

This study is part of a research project in which new ultrasound-based techniques will be examined to improve clinical decision making for patients with aortic stenosis. These patients could develop increased amounts of myocardial fibrosis. This fibrosis is associated with the patients' prognosis. Fibrosis can be evaluated with magnetic resonance imaging (MRI), which unfortunately is quite expensive and not easily available. Ultrasound-based parameters will be developed for the assessment of the amounts of myocardial fibrosis, especially in the left ventricle. Then it will be examined whether these parameters can predict the patients magnitude of fibrosis and check for association with the patients prognosis. MRI will serve as a gold standard for quantification of myocardial fibrosis. The new echocardiographic techniques and parameters are expected to provide new insights in the interplay between aortic stenosis and left ventricular function, and to ultimately improve the care for patients with aortic stenosis.

The present study's objectives are:

Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis compared with a healthy population.
Evaluate the patients outcome after one and three year of follow-up

Conditions: Aortic Valve Stenosis, Myocardial Fibrosis
Being tested: Echocardiography, MRI, Blood test, ECG and Holter-ECG, 6 min walking test
Keywords: Myocardium, Predictive Value of Tests, Prognosis, Clinical Decision-making, Heart Ventricles, Echocardiography
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.

EchocardiographyDiagnostic test
Also called GE Vingmed ultrasound scanner e95, 2017
Conventional transthoracic echocardiography will be performed, in addition 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 2.0) and in validated machine learning algorithms.
MRIDiagnostic test
Also called Magnetic resonance imaging
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. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings.
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 MRI/echocardiography.

Study groups in NCT03422770
Study group	Role	What they receive
Mild aortic stenosis	Other	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test
Moderate aortic stenosis	Other	25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test
Severe aortic stenosis	Other	50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: MRI; Diagnostic Test: Blood test; Diagnostic Test: ECG and Holter-ECG; Diagnostic Test: 6 min walking test
Controls	Other	31 subjects, all undergoing echocardiography and blood test and MRI. Receives: Diagnostic Test: 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.

Cardiovascular morbidity and mortality
Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)
Measured: 1 + 3 year

Secondary outcomes (4)

All cause mortality
Mortality in general
Measured: 3 years
Time of first re-hospitalisation
Time of first re-hospitalisation after inclusion
Measured: 3 years
Cardiac systolic function
Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE)
Measured: 1 year.
Cardiac diastolic function
Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow
Measured: 1 year.

Timeline

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

9 Jan 201830 Jun 2020

First posted6 Feb 2018
Study start9 Jan 2018
Primary completion30 Jun 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03422770
Sponsor's protocol ID: 2017/1068
Status last verified: Aug 2023
First submitted: 18 Jan 2018
Last updated: 16 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
ClinicalTrials.gov ID: NCT03422770
Acronym / sponsor ID: 2017/1068
Conditions: Aortic Valve Stenosis, Myocardial Fibrosis
Keywords: Myocardium, Predictive Value of Tests, Prognosis, Clinical Decision-making, Heart Ventricles, Echocardiography
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Norwegian University of Science and TechnologyUniversity, hospital or other
Collaborators: St. Olavs Hospital, Oslo University Hospital
Study start: 9 Jan 2018 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 6 Feb 2018 (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.

The present study's objectives are:

Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis compared with a healthy population.
Evaluate the patients outcome after one and three year of follow-up

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: All participants will undergo 'echo', bloodtests and MRI. Participating patients will in addition undergo electrocardiogram (ECG/Holter ECG) and 6 min walking test.

Arm	Type	Receives
Mild aortic stenosis	Other	Diagnostic Test: Echocardiography, Diagnostic Test: MRI, Diagnostic Test: Blood test, Diagnostic Test: ECG and Holter-ECG, Diagnostic Test: 6 min walking test25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Moderate aortic stenosis	Other	Diagnostic Test: Echocardiography, Diagnostic Test: MRI, Diagnostic Test: Blood test, Diagnostic Test: ECG and Holter-ECG, Diagnostic Test: 6 min walking test25 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Severe aortic stenosis	Other	Diagnostic Test: Echocardiography, Diagnostic Test: MRI, Diagnostic Test: Blood test, Diagnostic Test: ECG and Holter-ECG, Diagnostic Test: 6 min walking test50 patients, all undergoing echocardiography, MRI, blood test, questionnaires, 6 min walking test, ECG and Holter-ECG. All undergoing 1 year control.
Controls	Other	Diagnostic Test: Echocardiography, Diagnostic Test: MRI, Diagnostic Test: Blood test31 subjects, all undergoing echocardiography and blood test and MRI.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Able to undergo protocolled investigations
Patients: Mild, moderate or severe AS

Key exclusion criteria (8 listed)

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

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
EchocardiographyAlso: GE Vingmed ultrasound scanner e95, 2017Conventional transthoracic echocardiography will be performed, in addition 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 2.0) and in validated machine learning algorithms.	Diagnostic test	Controls, Mild aortic stenosis, Moderate aortic stenosis, Severe aortic stenosis
MRIAlso: Magnetic resonance imagingCardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.	Diagnostic test	Controls, Mild aortic stenosis, Moderate aortic stenosis, Severe aortic stenosis
Blood testConventional brachial venous blood samples will be drawn. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings.	Diagnostic test	Controls, Mild aortic stenosis, Moderate aortic stenosis, Severe aortic stenosis
ECG and Holter-ECGECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.	Diagnostic test	Mild aortic stenosis, Moderate aortic stenosis, Severe aortic stenosis
6 min walking test6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.	Diagnostic test	Mild aortic stenosis, Moderate aortic stenosis, Severe aortic stenosis

Primary outcome

Cardiovascular morbidity and mortality
Time frame: 1 + 3 year
Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)

4 secondary outcomes

All cause mortality
Time frame: 3 years
Time of first re-hospitalisation
Time frame: 3 years
Cardiac systolic function
Time frame: 1 year.
Cardiac diastolic function
Time frame: 1 year.

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 16 Aug 2023.
Derived from this study: PubMed 37676209Espeland 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.
Derived from this study: PubMed 32861651Salles 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.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

Svend Aakhus, MD PhD study director

Norwegian University of Science and Technology

Brage Høyem Amundsen, MD PhD study director

Norwegian University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Echocardiography, MRI and Blood test in people with 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 2 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 16 Aug 2023. 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 and mortality (time frame: 1 + 3 year). 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 NCT03422770, which also lists 2 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 16 Aug 2023.