ClinicalTrials.gov record NCT06129656
Cardiac Amyloidosis Registry of University Hospital Leipzig
Cardiac Amyloidosis Registry of University Hospital Leipzig
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a long-term observational registry for people with confirmed cardiac amyloidosis. It collects information recorded during routine care—symptoms, imaging, blood biomarkers, treatments, comorbidities, hospitalizations, and quality-of-life measures. Many measures are recorded every 3–12 months and key outcomes are tracked over years (registry target duration 20 years).
What it is studying. The registry aims to learn how cardiac amyloidosis presents and progresses in real-world clinical practice. It collects data on diagnostic tests and imaging, changes in biomarkers and heart structure/function, treatments used, comorbidities, hospitalizations, and long-term clinical outcomes.
What the researchers hope to learn. To describe the epidemiology and real-world clinical course of cardiac amyloidosis; to document use of diagnostic methods and treatments; to assess the impact of comorbidities; to validate and complement data from randomized trials; and to provide information about implementation, quality, monitoring, and safety of interventions.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Routine diagnostics
- Routine treatment
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Confirmed cardiac amyloidosis according to current standards
Exclusion criteria
- refusal to participate
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
The registry collects information from your routine clinical care: heart imaging results (echocardiography and cardiac MRI), clinical exams, serum biomarkers (for example NT‑proBNP and high‑sensitivity troponin T), medications, hospitalizations, functional tests, and quality-of-life questionnaires. Many measures are recorded repeatedly (the record lists clinical assessments and biomarkers often every 3–6 months, echocardiography or cardiac MRI about every 6–12 months, and some MRI measures approximately every 12 months) with key outcomes tracked over about 10 years and the registry target duration given as 20 years. The study records 6-minute walk test results, NYHA class, vital signs, signs of congestion, and any cardiovascular interventions that occur during care. The registry collects data from routine diagnostics and treatments; the record does not list additional study-specific invasive procedures.
How the study is structured. This is a prospective, observational registry (cohort) that collects data from routine diagnostics and routine treatment—no study treatment is assigned. Data recorded include echocardiography and cardiac MRI results, blood biomarkers (for example NT‑proBNP and high-sensitivity troponin T), 6-minute walk test results, quality-of-life questionnaires (e.g. KCCQ), vital signs, clinical signs of congestion, medication changes, and hospitalizations. Many measures are scheduled every 3–6 months, some imaging every 6–12 or about 12 months, and outcomes are followed for up to 10 years with a registry target duration of 20 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on ATTRv amyloidosis
This trial is also listed on this site under wild-type ATTR amyloidosis.
Important dates
- Study start
- May 1, 2023
- Primary completion
- May 2033 (estimated)
- Study completion
- May 2033 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Nov 13, 2023
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Leipzig
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Daniel Lavall, MD 📞 +493419712650 ✉ daniel.lavall@medizin.uni-leipzig.de
- Romy Gessner, MD 📞 +493419712650 ✉ romy.gessner@medizin.uni-leipzig.de
Participating sites (1)
- University Hospital LeipzigRecruiting
Leipzig, Saxony, 04103 · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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