Cardiac Amyloidosis Registry of University Hospital Leipzig

Condition(s) studied

Investigational drug(s) / intervention(s)

Routine diagnostics: Data collection of routine diagnostics

Routine treatment: Data collection of routine treatment

Study 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.

Eligibility

Primary outcome measure(s)

• All-cause and cardiac mortality — 10 years
  Mortality
• Cumulative rate of patients with worsening heart failure — 10 years
  Heart failure endpoint
• 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 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 extracellular volume values — Approx. every 12 months over 10 years
  Change in ECV 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
• Change in high-sensitivity cardiac troponin T over time — Every 3-6 months over 10 years
  Change in serum concentration of hs-cTnT
• 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.

Trial sites (1)

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