Cardiac Amyloidosis Registry of University Hospital Leipzig
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine diagnostics, Routine treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Amyloidosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Routine diagnostics
Data collection of routine diagnostics - Other Routine treatment
Data collection of routine treatment
Primary outcome measures
- All-cause and cardiac mortality [Time frame: 10 years]
- Cumulative rate of patients with worsening heart failure [Time frame: 10 years]
- Rate of any hospitalizations [Time frame: 10 years]
- Change in left ventricular ejection fraction [Time frame: Every 6-12 months over 10 years]
- Change in left ventricular wall thickness [Time frame: Every 6-12 months over 10 years]
- Change in systolic arterial pressure [Time frame: Every 6-12 months over 10 years]
- Change in T1 values [Time frame: Approx. every 12 months over 10 years]
- Change in extracellular volume values [Time frame: Approx. every 12 months over 10 years]
- Change in N-Terminal Pro-B-Type Natriuretic Peptide over time [Time frame: Every 3-6 months over 10 years]
- Change in high-sensitivity cardiac troponin T over time [Time frame: Every 3-6 months over 10 years]
Secondary outcome measures (7)
- Prevalence and incidence of cardiac and non-cardiac comorbidities [Time frame: Every 3-6 months over 10 years]
- New York Heart Association (NYHA) class over time [Time frame: Every 3-6 months over 10 years]
- Functional capacity over time [Time frame: Every 3-6 months over 10 years]
- Quality of life over time [Time frame: Every 3-6 months over 10 years]
- Vital signs over time [Time frame: Every 3-6 months over 10 years]
- Clinical signs of congestion over time [Time frame: Every 3-6 months over 10 years]
- Number of cardiovascular interventions [Time frame: Monitoring continuously over 10 years]
Eligibility criteria
Inclusion criteria
- Confirmed cardiac amyloidosis according to current standards
Exclusion criteria
- refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Leipzig — Leipzig
Identifiers
NCT: NCT06129656 · UKL_CA_registry