RecruitingNot Applicable

Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)

Switzerland300 participantsStarted 2001-02-22

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac event)

Timeframe: 5 years

LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE

Timeframe: 5 years

Late gadolinium enhancement as predictor for MACE

Timeframe: 5 years

Extracellular volume (ECV) as predictor for MACE

Timeframe: 5 years

Trial details

NCT IDNCT04776824

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-05-01

Contact for this trial

Christoph Gräni, MD, PhD

+41 31 632 4508 christoph.graeni@insel.ch

View on ClinicalTrials.gov More Amyloid Cardiomyopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac event)

Timeframe: 5 years

LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE

Timeframe: 5 years

Late gadolinium enhancement as predictor for MACE

Timeframe: 5 years

Extracellular volume (ECV) as predictor for MACE

Timeframe: 5 years