Cardiac Amyloidosis Registry of University Hospital Leipzig

NCT ID: NCT06129656

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2033-05-31

Brief Summary

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.

Conditions

Cardiac Amyloidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac Amyloidosis

Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital.

Routine diagnostics

Intervention Type: OTHER

Data collection of routine diagnostics

Routine treatment

Intervention Type: OTHER

Data collection of routine treatment

Interventions

Routine diagnostics

Data collection of routine diagnostics

Intervention Type: OTHER

Routine treatment

Data collection of routine treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed cardiac amyloidosis according to current standards

Exclusion Criteria

• refusal to participate

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Lavall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

University Hospital Leipzig

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Daniel Lavall, MD

Role: CONTACT

daniel.lavall@medizin.uni-leipzig.de

+493419712650

Romy Gessner, MD

Role: CONTACT

romy.gessner@medizin.uni-leipzig.de

+493419712650

Other Identifiers

UKL_CA_registry

Identifier Type: -

Identifier Source: org_study_id