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

Recruiting

• Conditions: Aortic Stenosis
• Interventions: Other: There is no intervention since it is an observational study patients are treated according to clinical praxis

• Registration Number: NCT05629104
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2020-07-17
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Primary Completion: 2024-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Accepted for aortic valve intervention

Exclusion Criteria

• No able to follow the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reduced heart function	There is no intervention since it is an observational study patients are treated according to clinical praxis	The group will be defined as reduced LVEF
Preserved heart function	There is no intervention since it is an observational study patients are treated according to clinical praxis	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of cardiology Uppsala University Hospital; 🇸🇪 Uppsala, Sweden