Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention

Study Overview
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Brief Summary
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Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. Imaging with echocardiography and computed tomography (CT) are performed together with additional imaging with magnetic resonance imaging (MRI) and Positron emissions tomography (PET)-CT in a subgroup of the study population. Blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. A follow up with information of the outcomes after 2-5 years will be performed through national registries.

Official Title
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Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Other: There is no intervention since it is an observational study patients are treated according to clinical praxis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accepted for aortic valve intervention Exclusion Criteria: No able to follow the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preserved heart function<br>The group will be defined as preserved left ventricular ejection fraction (LVEF) with and without hypertrophy and with and without reduced global longitudinal strain (GLS). | Other: There is no intervention since it is an observational study patients are treated according to clinical praxis<br>* No intervention<br>|
| Reduced heart function<br>The group will be defined as reduced LVEF | Other: There is no intervention since it is an observational study patients are treated according to clinical praxis<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semiquantitative assessment of protein levels associated with myocardial performance | Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden). | One year after intervention. | 
| Imaging parameters associated with clinical outcome after intervention | Global longitudinal strain (%) of the right and left ventricle. The clinical outcome defined as a combination of mortality and hospitalization of heart failure | One year after intervention | 
| Semiquantitative assessment of protein levels associated with myocardial performance associated with clinical outcome after intervention | Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden). The clinical outcome defined as a combination of mortality and hospitalization for heart failure. | Two years after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging parameters associated with clinical outcome after intervention | Volumes of the right and left ventricle (mL/m2). The clinical outcome defined as a combination of mortality and hospitalization for heart failure. | Two years after intervention |