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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629104
• Other study ID #: Bio-AS
• Status: Recruiting
• Start date: May 15, 2019
• Est. completion date: December 2027

Study information

• Verified date: November 2022
• Source: Uppsala University
• Contact: Christina Christersson, MD PhD
• Phone: +46186119068
• Email: christina.christersson[@]medsci.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Accepted for aortic valve intervention

Exclusion Criteria:

• No able to follow the study protocol

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Other:
• There is no intervention since it is an observational study patients are treated according to clinical praxis
No intervention

Locations

Country	Name	City	State
Sweden	Department of cardiology Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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