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NCT Number: NCT05629104

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

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of cardiology Uppsala University Hospital

Uppsala, 75185, Sweden

Location status: Recruiting

Location contact

Christina Christersson, MD PhD

CONTACT

[email protected]

+46186119068

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Accepted for aortic valve intervention

Exclusion criteria

  • No able to follow the study protocol

Treatment and study plan

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

Other

No intervention

Primary outcomes

  1. 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).

  2. 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

  3. 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

  1. Imaging parameters associated with clinical outcome after intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Christersson, MD PhD

CONTACT

[email protected]

+46186119068

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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