Aortic Valve Stenosis, Myocardial Fibrosis
Conditions
Keywords
Myocardium, Predictive Value of Tests, Prognosis, Clinical Decision-making, Heart Ventricles, Echocardiography
Brief summary
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
Interventions
DIAGNOSTIC_TESTEchocardiography
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.
DIAGNOSTIC_TESTMRI
Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
DIAGNOSTIC_TESTBlood 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.
DIAGNOSTIC_TESTECG and Holter-ECG
ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.
DIAGNOSTIC_TEST6 min walking test
6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.
Sponsors
St. Olavs Hospital
Oslo University Hospital
Norwegian University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Analysis will be blinded
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 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-yrs prognosis (cancer, pulmonary disease) * Severely reduced image-quality (echocardiography and MRI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular morbidity and mortality | 1 + 3 year | Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 3 years | Mortality in general |
| Time of first re-hospitalisation | 3 years | Time of first re-hospitalisation after inclusion |
| Cardiac systolic function | 1 year. | Echocardiographic systolic function based on left ventricular ejection fraction, global longitudinal strain, mitral annular plane systolic excursion (MAPSE) |
| Cardiac diastolic function | 1 year. | Echocardiographic diastolic function based on the volume of the left atrium, the tricuspidal regurgitation, mitral annular velocities and mitral flow |
Countries
Norway
Outcome results
None listed