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

NCT ID: NCT05629104

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

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

Intervention Type OTHER

No intervention

Reduced heart function

The group will be defined as reduced LVEF

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

Intervention Type OTHER

No intervention

Interventions

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

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Accepted for aortic valve intervention

Exclusion Criteria

* No able to follow the study protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Christersson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

VO hjärt-lungmedicin och klinisk fysiologi Akademiska Sjukhuset

Locations

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Department of cardiology Uppsala University Hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Christina Christersson, MD PhD

Role: CONTACT

+46186119068

Facility Contacts

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Christina Christersson, MD PhD

Role: primary

+46186119068

Other Identifiers

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Bio-AS

Identifier Type: -

Identifier Source: org_study_id

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