Essen Amyloidosis Registry

NCT06887283 | Recruiting DMC

• 1 other identifier: EAR-WDAZ1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amyloidosis; Systemic; Amyloidosis Cardiac

Keywords

Amyloidosis; Transthyretin; Light chain amyloidosis; Neuropathy; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Suspected or confirmed amyloidosis (any)
• Written informed consent to participate in the study
• Age 18 years and above

You may not qualify if:

• Age \< 18 years
• Lack of written informed consent

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood biobank samples

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis; Amyloid Neuropathies, Familial; Amyloidosis; Cardiomyopathies

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lars Michel, MD

CONTACT

+49 201 72384841; lars.michel@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: May 8, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 21, 2025

Record last verified: 2025-03

Locations

DE (1)