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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05629104

Enrollment

300

Registered

2022-11-29

Start date

2019-05-15

Completion date

2027-12-31

Last updated

2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

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.

Interventions

OTHERThere is no intervention since it is an observational study patients are treated according to clinical praxis

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Accepted for aortic valve intervention

Exclusion criteria

* No able to follow the study protocol

Design outcomes

Primary

Measure	Time frame	Description
Semiquantitative assessment of protein levels associated with myocardial performance	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	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	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

Measure	Time frame	Description
Imaging parameters associated with clinical outcome after intervention	Two years 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.

Countries

Sweden

Contacts

Primary ContactChristina Christersson, MD PhD

christina.christersson@medsci.uu.se+46186119068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026