Cardiac Amyloidosis Registry of University Hospital Leipzig

Study Overview
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Brief Summary
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This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.

Detailed Description
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Cardiac amyloidosis is increasingly diagnosed since awareness of the disease and therapeutic options increase. There is evidence from clinical trials about warning signs (red flags), diagnostic algorithms, and evidence for specific treatment. However, patients in randomized clinical studies are highly selected and do not necessarily reflect clinical practise. Furthermore, large clinical trials do not account for national medical care differences nor provide data about long-term outcome and the associations with comorbidities. Clinical registries may reflect broad clinical practise and help to characterize cardiac amyloidosis in terms of epidemiology, application of diagnostic methods, the impact of comorbidities, and real-world clinical course. Furthermore, clinical registry studies may validate data from randomized clinical trials, provide information on implementation of treatment, the quality of interventions, monitoring patients during treatment, and inform about the safety of procedures. The cardiac amyloidosis registry aims to collect data from the routine clinical management of patients with cardiac amyloidosis at the tertiary care University Hospital Leipzig. In particular, obtaining data about clinical events of heart disease, hemodynamic measures from echocardiography and circulation biomarkers, cardiac morphology from different imaging methods, clinical status, functional capacity, quality of life, and impact of comorbidities during the course of the disease will be the goal of this registry.

Official Title
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Cardiac Amyloidosis Registry of University Hospital Leipzig

Conditions
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Cardiac Amyloidosis

Intervention / Treatment
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* Other: Routine diagnostics
* Other: Routine treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed cardiac amyloidosis according to current standards Exclusion Criteria: refusal to participate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Amyloidosis<br>Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital. | Other: Routine diagnostics<br>* Data collection of routine diagnostics<br>Other: Routine treatment<br>* Data collection of routine treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiac mortality | Mortality | 10 years | 
| Cumulative rate of patients with worsening heart failure | Heart failure endpoint | 10 years | 
| Rate of any hospitalizations | Record of any clinical events requiring hospitalization | 10 years | 
| Change in left ventricular ejection fraction | Change in LVEF assessed by echocardiography or cardiac MRI | Every 6-12 months over 10 years | 
| Change in left ventricular wall thickness | Change in left ventricular wall thickness/ mass assessed by echocardiography or cardiac MRI | Every 6-12 months over 10 years | 
| Change in systolic arterial pressure | Change in sPAP assessed by echocardiography | Every 6-12 months over 10 years | 
| Change in T1 values | Change in T1 values assessed by cardiac MRI | Approx. every 12 months over 10 years | 
| Change in extracellular volume values | Change in ECV assessed by cardiac MRI | Approx. every 12 months over 10 years | 
| Change in N-Terminal Pro-B-Type Natriuretic Peptide over time | Change in serum concentration of NT-proBNP | Every 3-6 months over 10 years | 
| Change in high-sensitivity cardiac troponin T over time | Change in serum concentration of hs-cTnT | Every 3-6 months over 10 years | 
| Changes in medical treatment for heart failure | Changes in heart failure medication (i.e. diuretics, beta-blocker, renin-angiotensin system inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter type 2 inhibitors) as well as specific treatment for amyloidosis (e.g. tafamidis) is recorded. | Every 3-6 months over 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and incidence of cardiac and non-cardiac comorbidities | Medical history and reports regarding any comorbidities and previous treatment will be assessed in detail at inclusion. Patients are asked for new comorbidities and new treatments at every visit. | Every 3-6 months over 10 years | 
| New York Heart Association (NYHA) class over time | As parameter of clinical status | Every 3-6 months over 10 years | 
| Functional capacity over time | Measured using 6 minute walk test | Every 3-6 months over 10 years | 
| Quality of life over time | Measured via questionnaire (e.g. KCCQ) | Every 3-6 months over 10 years | 
| Vital signs over time | Blood pressure | Every 3-6 months over 10 years | 
| Clinical signs of congestion over time | E.g. edema, jugular venous distension, crackles on lung auscultation | Every 3-6 months over 10 years | 
| Number of cardiovascular interventions | Indication, efficacy and safety of any cardiovascular intervention will be recorded, such as rate of pacemaker implantations, numbers of valve procedures (aortic valve implantation, mitral or tricuspid valve clipping), left atrial appendage occluder implantation, electrophysiological studies and ablation procedures | Monitoring continuously over 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, cardiac amyloidosis, restrictive cardiomyopathy