Amyloidosis; SystemicEARNCT06887283
Essen Amyloidosis Registry
An observational study of Amyloidosis; Systemic and Amyloidosis Cardiac, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The Essen Amyloidosis Registry (EAR) is a prospective, observational registry designed to collect comprehensive clinical data on patients diagnosed with systemic amyloidosis. The registry aims to improve the understanding of disease progression, diagnostic pathways, and treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis; Systemic, Amyloidosis Cardiac
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 8 May 2024to 1 Jul 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with suspected or confirmed amyloidosis treated at the University Hospital Duisburg-Essen are screened for inclusion. A particular focus of the registry lies on amyloid cardiomyopathy and amyloid polyneuropathy.
Who may be able to join
- Suspected or confirmed amyloidosis (any)
- Written informed consent to participate in the study
- Age 18 years and above
Who cannot join
- Age < 18 years
- Lack of written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen
Essen, North Rhine-Westphalia, 45147
Lars Michel, MD, +49 201 72384841, lars.michel@uk-essen.de
About this study
The Essen Amyloidosis Registry (EAR) is a prospective, observational registry designed to collect comprehensive clinical data on patients diagnosed with systemic amyloidosis. The registry aims to improve the understanding of disease progression, diagnostic pathways, and treatment outcomes. The registry is hosted at the University Hospital Essen and follows patients longitudinally. Inclusion is open to all patients with suspected or confirmed amyloidosis who provide informed consent.
Read the detailed description
The Essen Amyloidosis Registry (EAR) is a single-center, prospective, observational registry designed to systematically collect clinical, laboratory, imaging, and outcome data from patients with suspected or confirmed systemic amyloidosis. The registry aims to improve the understanding of disease characteristics, diagnostic pathways, and treatment outcomes. While cardiac amyloidosis remains a main focus, EAR includes all forms of systemic amyloidosis, such as light-chain (AL) amyloidosis, transthyretin amyloidosis (ATTR, both hereditary and wild-type), and rarer subtypes.
Data collected include demographic information, medical history, comorbidities, diagnostic findings, treatment strategies, and longitudinal follow-up data on disease progression and therapy response. Standardized assessments include serial laboratory tests, cardiac and other imaging modalities (e.g., echocardiography, cardiac MRI, scintigraphy), and functional status evaluations. Routine quality-of-life assessments, as part of standard clinical practice, are also documented. Patients will not be required to complete additional study-specific questionnaires.
The registry further integrates a biobank component, in which biological samples are collected for biomarker analysis. Given the current limitations of available diagnostics-such as insufficient sensitivity for early disease detection and a lack of robust markers for therapy monitoring-these biospecimens may help identify new prognostic and predictive biomarkers.
EAR enables the analysis of risk factors, disease progression, and long-term outcomes based on real-world clinical data. The registry also serves as an internal quality control tool, ensuring standardized data collection and treatment monitoring. Patients remain under regular clinical follow-up, with routine evaluations every 3 to 6 months, depending on their disease stage and treatment regimen. These visits typically include resting ECGs, blood tests, imaging studies, and device checks (for patients with pacemakers or defibrillators).
The Essen Amyloidosis Registry aims to create a comprehensive dataset that can be utilized for future research projects. Sub-projects addressing specific scientific questions will be submitted as separate ethics applications. The study follows standard clinical care guidelines, with examinations performed according to established Standard Operating Procedures (SOPs) for amyloidosis management.
- Conditions
- Amyloidosis; Systemic, Amyloidosis Cardiac
- Keywords
- Amyloidosis, Transthyretin, Light chain amyloidosis, Neuropathy, Cardiomyopathy
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Amyloid Neuropathies, Familial, Amyloidosis, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality or unplanned hospitalization for heart failure
Overall mortality or unplanned hospitalization for heart failure is defined as the primary endpoint. The time to the primary endpoint will be measured in days starting from the day of first diagnosis of cardiac amyloidosis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start8 May 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis; SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887283
- Sponsor's protocol ID
- EAR-WDAZ1
- Acronym
- EAR
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is planned as a monocentric registry but is open to requests of scientific cooperation.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essen Amyloidosis Registry
- ClinicalTrials.gov ID
- NCT06887283
- Acronym / sponsor ID
- EAR / EAR-WDAZ1
- Conditions
- Amyloidosis; Systemic, Amyloidosis Cardiac
- Keywords
- Amyloidosis, Transthyretin, Light chain amyloidosis, Neuropathy, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Essen Amyloidosis Registry (EAR) is a prospective, observational registry designed to collect comprehensive clinical data on patients diagnosed with systemic amyloidosis. The registry aims to improve the understanding of disease progression, diagnostic pathways, and treatment outcomes. The registry is hosted at the University Hospital Essen and follows patients longitudinally. Inclusion is open to all patients with suspected or confirmed amyloidosis who provide informed consent.
Detailed description
The Essen Amyloidosis Registry (EAR) is a single-center, prospective, observational registry designed to systematically collect clinical, laboratory, imaging, and outcome data from patients with suspected or confirmed systemic amyloidosis. The registry aims to improve the understanding of disease characteristics, diagnostic pathways, and treatment outcomes. While cardiac amyloidosis remains a main focus, EAR includes all forms of systemic amyloidosis, such as light-chain (AL) amyloidosis, transthyretin amyloidosis (ATTR, both hereditary and wild-type), and rarer subtypes.
Data collected include demographic information, medical history, comorbidities, diagnostic findings, treatment strategies, and longitudinal follow-up data on disease progression and therapy response. Standardized assessments include serial laboratory tests, cardiac and other imaging modalities (e.g., echocardiography, cardiac MRI, scintigraphy), and functional status evaluations. Routine quality-of-life assessments, as part of standard clinical practice, are also documented. Patients will not be required to complete additional study-specific questionnaires.
The registry further integrates a biobank component, in which biological samples are collected for biomarker analysis. Given the current limitations of available diagnostics-such as insufficient sensitivity for early disease detection and a lack of robust markers for therapy monitoring-these biospecimens may help identify new prognostic and predictive biomarkers.
EAR enables the analysis of risk factors, disease progression, and long-term outcomes based on real-world clinical data. The registry also serves as an internal quality control tool, ensuring standardized data collection and treatment monitoring. Patients remain under regular clinical follow-up, with routine evaluations every 3 to 6 months, depending on their disease stage and treatment regimen. These visits typically include resting ECGs, blood tests, imaging studies, and device checks (for patients with pacemakers or defibrillators).
The Essen Amyloidosis Registry aims to create a comprehensive dataset that can be utilized for future research projects. Sub-projects addressing specific scientific questions will be submitted as separate ethics applications. The study follows standard clinical care guidelines, with examinations performed according to established Standard Operating Procedures (SOPs) for amyloidosis management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected or confirmed amyloidosis treated at the University Hospital Duisburg-Essen are screened for inclusion. A particular focus of the registry lies on amyloid cardiomyopathy and amyloid polyneuropathy.
Key inclusion criteria (3 listed)
- Suspected or confirmed amyloidosis (any)
- Written informed consent to participate in the study
- Age 18 years and above
Key exclusion criteria (2 listed)
- Age < 18 years
- Lack of written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall mortality or unplanned hospitalization for heart failure
Time frame: 24 months
Overall mortality or unplanned hospitalization for heart failure is defined as the primary endpoint. The time to the primary endpoint will be measured in days starting from the day of first diagnosis of cardiac amyloidosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided. The study is planned as a monocentric registry but is open to requests of scientific cooperation.
Related trials for Amyloidosis; Systemic
RecruitingObservational study
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingPhase 1
Phase 1a/b Study of GPRC5D CART Therapy in Relapsed/Refractory Multiple Myeloma and Light-chain Amyloidosis
Relapsed/Refractory Multiple Myeloma (RRMM), Light-Chain Amyloidosis
Active, not recruitingPhase 1
Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.
Multiple Myeloma, Amyloidosis
Active, not recruitingPhase 1/2
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
AL Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis; Systemic and Amyloidosis Cardiac, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Michel, MD (+49 201 72384841, lars.michel@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality or unplanned hospitalization for heart failure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.