Swiss Cardiac Amyloidosis REgistry (Swiss-CARE) (B-CARE)
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| ClinicalTrials.gov Identifier: NCT04776824 |
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Recruitment Status :
Recruiting
First Posted : March 2, 2021
Last Update Posted : October 6, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | February 25, 2021 | ||||||||
| First Posted Date | March 2, 2021 | ||||||||
| Last Update Posted Date | October 6, 2023 | ||||||||
| Actual Study Start Date | February 22, 2001 | ||||||||
| Estimated Primary Completion Date | May 1, 2031 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Swiss Cardiac Amyloidosis REgistry (Swiss-CARE) | ||||||||
| Official Title | Swiss Cardiac Amyloidosis REgistry (Swiss-CARE) | ||||||||
| 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. |
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| 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | 10 Years | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: 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.
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Confirmed diagnosis of amyloidosis w/wo cardiac involvement | ||||||||
| Condition | Amyloid Cardiomyopathy | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Patients with confirmed amyloidosis
Confirmed diagnosis of amyloidosis w/wo cardiac involvement
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 1, 2031 | ||||||||
| Estimated Primary Completion Date | May 1, 2031 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04776824 | ||||||||
| Other Study ID Numbers | 2021-00135 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Insel Gruppe AG, University Hospital Bern | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Insel Gruppe AG, University Hospital Bern | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Insel Gruppe AG, University Hospital Bern | ||||||||
| Verification Date | October 2023 | ||||||||