ClinicalTrials.gov record NCT04776824

Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationSwitzerland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A registry collecting clinical and cardiac MRI data from people with confirmed amyloidosis, with or without heart involvement. The study combines retrospective and prospective data and repeats CMR scans, with clinical and lab follow-up every 3–6 months. Imaging before and during the first 18 months after therapy start will be analyzed and participants are followed long term.

What it is studying. The study tests whether CMR feature tracking, T1 and T2 mapping, late gadolinium enhancement (LGE) and extracellular volume (ECV) measurements relate to disease severity and predict major adverse cardiac events (MACE). It also examines whether these imaging markers can help identify patients for ongoing transthyretin (TTR) stabilizing therapy.

What the researchers hope to learn. To evaluate whether specific CMR measurements (feature tracking, T1/T2 mapping, LGE, ECV) predict major adverse cardiac events and reflect disease severity, to assess their value for monitoring treatment response, and to inform selection of patients for TTR‑stabilizing therapy and health‑care decision making.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Cardiac transthyretin amyloidosis (ATTR), caused by ventricular depositions of misfolded transthyretin, results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, diastolic and systolic dysfunction to the development of terminal heart failure. Recently, treatment options for TTR amyloidosis have become available. However costs for therapy are enormous and previous trials were not able to differentiate between patients that might benefit from treatment and those without a need for treatment. 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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Confirmed diagnosis of amyloidosis w/wo cardiac involvement
  • General Consent

Exclusion criteria

  • Inability to give consent or existence of a written or documented oral refusal of the data subject.<18 years of age

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Cardiac transthyretin amyloidosis (ATTR), the most common amyloidosis form with cardiac involvement, is caused by tissue deposition of misfolded TTR, a transport Protein for thyroxine and retinol. Ventricular depositions of amyloid fibrils results in an infiltrative cardiomyopathy, progressing from pronounced myocardial wall thickening, to diastolic and systolic dysfunction and finally chronic heart failure. 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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will have cardiac magnetic resonance (CMR) scans that include standard imaging plus feature-tracking and T1- and T2-mapping; some scans will use gadolinium contrast to assess late gadolinium enhancement and extracellular volume (ECV). CMR is performed before and repeatedly over the course of 18 months after therapy initiation. Clinical and laboratory follow-up visits occur every 3–6 months, and haematocrit is measured for ECV calculation. The study collects both retrospective and prospective data and follows cardiac outcomes over multiple years (primary imaging outcomes assessed up to 5 years; target study duration 10 years).

How the study is structured. An observational, case-only registry that collects existing (retrospective) and new (prospective) data from people with amyloid cardiomyopathy. There is no assigned treatment from the study; participants have CMR scans and clinical/laboratory follow-up over time. CMR assessments are planned before and during the first 18 months after therapy start, clinical and lab follow-up occurs every 3–6 months, and the registry plans long-term follow-up (target duration 10 years) with primary imaging outcomes assessed up to 5 years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Switzerland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 22, 2001
Primary completion
May 1, 2031 (estimated)
Study completion
May 1, 2031 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
May 6, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Insel Gruppe AG, University Hospital Bern

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (7)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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