ClinicalTrials.gov record NCT06129656

Cardiac Amyloidosis Registry of University Hospital Leipzig

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Cardiac Amyloidosis Registry of University Hospital Leipzig

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Nov 13, 2023, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationGermany
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.

A prospective clinical registry of people with confirmed cardiac amyloidosis treated at the University Hospital Leipzig. The study collects routine diagnostic, imaging, biomarker, treatment, and outcome data from regular clinical care. Participants are followed long-term (registry target 20 years), with many measures recorded regularly over the first 10 years. The registry aims to describe real-world disease course and care outside randomized trials.

What it is studying. The registry aims to learn how cardiac amyloidosis is diagnosed, treated, and how it progresses in routine clinical practice; it collects data on symptoms, imaging, blood biomarkers, treatments, hospitalizations, and mortality to describe real-world outcomes and the impact of comorbidities.

What the researchers hope to learn. Describe the epidemiology and real-world clinical course of cardiac amyloidosis; assess use and results of diagnostic methods and imaging; record the impact of comorbidities; document treatments given in practice and the quality and safety of interventions; provide long-term outcome and hospitalization data.

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.

Participants allow the study team to collect information from their routine care over time. Collected data may include imaging (echocardiography and cardiac MRI), blood biomarker results (for example NT-proBNP and hs-cTnT), functional tests (6-minute walk), quality-of-life questionnaires, records of hospitalizations, and details of any cardiovascular procedures. Imaging is commonly recorded about every 6–12 months and many clinical measures are tracked roughly every 3–6 months; outcomes in the record are followed over years (many measures reported over 10 years; a 20-year target duration is listed). Any invasive procedures (for example pacemaker implantation, valve procedures, electrophysiology studies/ablations) are only recorded if they occur as part of usual clinical care.

How the study is structured. This is an observational, prospective registry (a cohort). It does not assign experimental treatments. Study staff collect data from participants' routine clinical visits, tests, imaging, and treatments. Many measures are recorded every 3–6 months; some imaging measures are captured every 6–12 or about 12 months. The registry has a long-term follow-up plan (target duration 20 years; many outcomes tracked over 10 years).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • 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 wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

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.

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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