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)

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Other: There is no intervention since it is an observational study patients are treated according to clinical praxis

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Christina Christersson, MD PhD; Phone Number: +46186119068; Email: christina.christersson@medsci.uu.se

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Recruiting
    • Department of cardiology Uppsala University Hospital
    • Contact: Christina Christersson, MD PhD; Phone Number: +46186119068; Email: christina.christersson@medsci.uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients accepted for aortic valve intervention due to aortic stenosis

Description

Inclusion Criteria:

• Accepted for aortic valve intervention

Exclusion Criteria:

• No able to follow the study protocol

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preserved heart function; 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; No intervention
Reduced heart function; 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; No intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Christina Christersson, MD PhD, VO hjärt-lungmedicin och klinisk fysiologi Akademiska Sjukhuset

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: Bio-AS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No