Study Results
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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RECRUITING
300 participants
OBSERVATIONAL
2001-02-22
2031-05-01
Brief Summary
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the investigators study aims to determine markers, as assessed by cardiac magnet resonance imaging (CMR) feature tracking (FT) and T1- and T2- mapping, that might reliably indicate disease severity and could help to identify patients that might benefit from (ongoing) TTR stabilization treatment.
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Detailed Description
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While treatment options are now available, it remains unclear how to monitor therapy response and disease progression. No makers have been identified that predict outcome prior to initiation of therapy, thus patient selection for therapy remains challenging.
The investigators study will address these issues and will provide systematically assessed CMR data before and over the course of 18 months after therapy initiation. Clinical and laboratory follow-up will be performed every 3-6 months. The investigators study is based on an open, uncontrolled, structured collection of retrospective and prospective data from all patients diagnosed with amyloidosis at the Inselspital Bern with the aim to follow patients undergoing therapy.
The investigators hypothesize that CMR feature tracking (FT) and measures of T1- and T2- mapping, such as extracellular volume (ECV) may better correlate with disease severity and help to identify patients likely to benefit from (ongoing) TTR stabilizing therapy. Beside standard CMR assessments, the investigators will use CMR feature tracking to quantify global and regional myocardial function. FT has proven to be an excellent predictor in various cardiomyopathies.
The proposed study will evaluate the potential of CMR to identify patients likely to benefit from therapy, monitor treatment response and balance individual patient benefit and health care cost.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with confirmed amyloidosis
Confirmed diagnosis of amyloidosis w/wo cardiac involvement
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* General Consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Christoph Gräni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Locations
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USB
Basel, , Switzerland
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Bern, , Switzerland
HUG
Geneva, , Switzerland
CHUV
Lausanne, , Switzerland
LUKS
Lucerne, , Switzerland
KSSG
Sankt Gallen, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-00135
Identifier Type: -
Identifier Source: org_study_id
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