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

NCT05629104 | Recruiting

• 1 other identifier: Bio-AS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Imaging parameters associated with clinical outcome after intervention

  Two years after intervention

Study Arms (2)

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

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

Interventions

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

No intervention

Preserved heart function; Reduced heart function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients accepted for aortic valve intervention due to aortic stenosis

You may qualify if:

• Accepted for aortic valve intervention

You may not qualify if:

• No able to follow the study protocol

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of cardiology Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina Christersson, MD PhD

  VO hjärt-lungmedicin och klinisk fysiologi Akademiska Sjukhuset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Christersson, MD PhD

CONTACT

+46186119068; christina.christersson@medsci.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: November 29, 2022
• Study Start: May 15, 2019
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)