Aortic Valve Stenosis, Myocardial Fibrosis
Conditions
Keywords
High frame rate echocardiography, Heart failure, Aortic stenosis, Cardiac MRI, Prognosis, Quantification of severity
Brief 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. 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.
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.
Interventions
DIAGNOSTIC_TESTHigh frame rate echocardiography
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.
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. Hematocrit value {in %} will be used to calculate CMR-derived exttracellular volume (ECV)
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 CMRI/echocardiography.
Sponsors
St. Olavs Hospital
Oslo University Hospital
Norwegian University of Science and Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular morbidity | 5 year | Admissions with heart failure |
| Cardiovascular mortality | 5 year | Death caused by cardiac disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of first re-hospitalization | 5 years | Time of first re-hospitalization after inclusion |
| Cardiac systolic function | 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) |
| Cardiac diastolic function (1 of 5) | 5 years | Echocardiographic diastolic function based on i) left atrial volume index {ml/m\^2). |
| Cardiac diastolic function (3 of 5) | 5 years | Echocardiographic diastolic function based on iii) mitral inflow velocities {cm/sec} |
| Cardiac diastolic function (4 of 5) | 5 years | Echocardiographic diastolic function based on iv) ricuspid regurgitation velocity {cm/sec} |
| Cardiac diastolic function (5 of 5) | 5 years | Echocardiographic diastolic function based on v) E/è-ratio |
| Velocity of natural mechanical waves propagating through the myocardium | 5 years | Investigate for prognotisc value and if it can be a marker of diastolic dysfunction. Unit of velocity measurement is m/sec. |
| Cardiac diastolic function (2 of 5) | 5 years | Echocardiographic diastolic function based on ii) mitral annular velocities {cm/sec} |
| All cause mortality | 5 years | Mortality in general |
Countries
Norway
Outcome results
None listed