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Swiss Cardiac Amyloidosis REgistry (Swiss-CARE) (B-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776824
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : October 6, 2023
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
Luzerner Kantonsspital
Triemli Hospital
Information provided by (Responsible Party):
Insel Gruppe AG, University Hospital Bern

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease
Amyloid Cardiomyopathy

Detailed Description:

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Swiss Cardiac Amyloidosis REgistry (Swiss-CARE)
Actual Study Start Date : February 22, 2001
Estimated Primary Completion Date : May 1, 2031
Estimated Study Completion Date : May 1, 2031

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Patients with confirmed amyloidosis
Confirmed diagnosis of amyloidosis w/wo cardiac involvement


Outcome Measures
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Primary Outcome Measures :
  1. LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac event) [ Time Frame: 5 years ]
    Global and regional longitudinal (%), circumferential (%) and radial (%) strain measurements are used to quantify LV and RV function before and after therapy initiation. MACE is defined as a composite of sustained ventricular tachycardia, hospitalization for heart failure and all-cause death.

  2. LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE [ Time Frame: 5 years ]
    Global and regional tissue characteristics are assessed by repetitive T1 and T2 mapping (global and regional T1 and T2 time (ms)) before and during therapy. MACE is defined as a composite of major cardiovascular endpoints listed above.

  3. Late gadolinium enhancement as predictor for MACE [ Time Frame: 5 years ]
    Global and regional myocardial tissue is characterized by gadolinium contrast agent application. The presence and extent (% and total mass (g)) of late gadolinium enhancement is evaluated as a predictor for MACE.

  4. Extracellular volume (ECV) as predictor for MACE [ Time Frame: 5 years ]
    ECV (%) as a marker of myocardial tissue remodelling is calculated from native and post-contrast T1 mapping and haematocrit before and during therapy.


Biospecimen Retention:   Samples Without DNA
Genetic testing is a part of the routine diagnostic work-up of TTR amyloidosis patients. Current knowledge suggests that therapy response and clinical outcome may differ in TTR patients suffering from wt-TTR and h-/m-TTR-amyloidosis, respectively. Therefore, the genetic background should also be assessed as part of the registry.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Confirmed diagnosis of amyloidosis w/wo cardiac involvement
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776824


Contacts
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Contact: Christoph Gräni, MD, PhD +41 31 632 4508 christoph.graeni@insel.ch
Contact: Adam Bakula, MD, PhD +41 31 66 4 54 22 adam.bakula@insel.ch

Locations
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Switzerland
Department of Cardiology, University Hospital Bern, Inselspital, Bern Recruiting
Bern, Switzerland, 3010
Contact: Christoph Gräni, Prof    +41316324508    christoph.graeni@insel.ch   
Sponsors and Collaborators
Insel Gruppe AG, University Hospital Bern
Cantonal Hospital of St. Gallen
Luzerner Kantonsspital
Triemli Hospital
Investigators
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Principal Investigator: Christoph Gräni, MD, PhD Department of Cardiology, University Hospital Bern, Inselspital, Bern
More Information
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Responsible Party: Insel Gruppe AG, University Hospital Bern
ClinicalTrials.gov Identifier: NCT04776824    
Other Study ID Numbers: 2021-00135
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: October 6, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Insel Gruppe AG, University Hospital Bern:
Cardiac Amyloidosis
Tafamidis
CMR feature tracking
 Strain
T1 and T2 Mapping
Outcomes
Additional relevant MeSH terms:
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Cardiomyopathies
Amyloidosis
Heart Diseases
 Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases