Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Uppsala University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Semiquantitative assessment of protein levels associated with myocardial performance
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Accepted for aortic valve intervention
Exclusion Criteria
- •No able to follow the study protocol
Outcomes
Primary Outcomes
Semiquantitative assessment of protein levels associated with myocardial performance
Time Frame: One year after intervention.
Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden).
Imaging parameters associated with clinical outcome after intervention
Time Frame: One year 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
Semiquantitative assessment of protein levels associated with myocardial performance associated with clinical outcome after intervention
Time Frame: Two years 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.
Secondary Outcomes
- Imaging parameters associated with clinical outcome after intervention(Two years after intervention)