Cardiac Amyloidosis Registry of University Hospital Leipzig
- Conditions
- Cardiac Amyloidosis
- Interventions
- Other: Routine diagnosticsOther: Routine treatment
- Registration Number
- NCT06129656
- Lead Sponsor
- University of Leipzig
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Confirmed cardiac amyloidosis according to current standards
- refusal to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiac Amyloidosis Routine treatment Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital. Cardiac Amyloidosis Routine diagnostics Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital.
- Primary Outcome Measures
Name Time Method All-cause and cardiac mortality 10 years Mortality
Change in high-sensitivity cardiac troponin T over time Every 3-6 months over 10 years Change in serum concentration of hs-cTnT
Rate of any hospitalizations 10 years Record of any clinical events requiring hospitalization
Change in left ventricular ejection fraction Every 6-12 months over 10 years Change in LVEF assessed by echocardiography or cardiac MRI
Change in left ventricular wall thickness Every 6-12 months over 10 years Change in left ventricular wall thickness/ mass assessed by echocardiography or cardiac MRI
Change in extracellular volume values Approx. every 12 months over 10 years Change in ECV assessed by cardiac MRI
Changes in medical treatment for heart failure Every 3-6 months over 10 years 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.
Cumulative rate of patients with worsening heart failure 10 years Heart failure endpoint
Change in systolic arterial pressure Every 6-12 months over 10 years Change in sPAP assessed by echocardiography
Change in T1 values Approx. every 12 months over 10 years Change in T1 values assessed by cardiac MRI
Change in N-Terminal Pro-B-Type Natriuretic Peptide over time Every 3-6 months over 10 years Change in serum concentration of NT-proBNP
- Secondary Outcome Measures
Name Time Method Vital signs over time Every 3-6 months over 10 years Blood pressure
Functional capacity over time Every 3-6 months over 10 years Measured using 6 minute walk test
Clinical signs of congestion over time Every 3-6 months over 10 years E.g. edema, jugular venous distension, crackles on lung auscultation
Prevalence and incidence of cardiac and non-cardiac comorbidities Every 3-6 months over 10 years 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.
New York Heart Association (NYHA) class over time Every 3-6 months over 10 years As parameter of clinical status
Quality of life over time Every 3-6 months over 10 years Measured via questionnaire (e.g. KCCQ)
Number of cardiovascular interventions Monitoring continuously over 10 years 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
Trial Locations
- Locations (1)
University Hospital Leipzig
🇩🇪Leipzig, Saxony, Germany