Cardiac Amyloidosis Registry of University Hospital Leipzig

NCT06129656 | Recruiting

• 1 other identifier: UKL_CA_registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Keywords

heart failure; cardiac amyloidosis; restrictive cardiomyopathy

Outcome Measures

Primary Outcomes (11)

• All-cause and cardiac mortality

  Mortality

  10 years

• Cumulative rate of patients with worsening heart failure

  Heart failure endpoint

  10 years

• Rate of any hospitalizations

  Record of any clinical events requiring hospitalization

  10 years

• Change in left ventricular ejection fraction

  Change in LVEF assessed by echocardiography or cardiac MRI

  Every 6-12 months over 10 years

• Change in left ventricular wall thickness

  Change in left ventricular wall thickness/ mass assessed by echocardiography or cardiac MRI

  Every 6-12 months over 10 years

• Change in systolic arterial pressure

  Change in sPAP assessed by echocardiography

  Every 6-12 months over 10 years

• Change in T1 values

  Change in T1 values assessed by cardiac MRI

  Approx. every 12 months over 10 years

• Change in extracellular volume values

  Change in ECV assessed by cardiac MRI

  Approx. every 12 months over 10 years

• Change in N-Terminal Pro-B-Type Natriuretic Peptide over time

  Change in serum concentration of NT-proBNP

  Every 3-6 months over 10 years

• Change in high-sensitivity cardiac troponin T over time

  Change in serum concentration of hs-cTnT

  Every 3-6 months over 10 years

• Changes in medical treatment for heart failure

  Changes in heart failure medication (i.e. diuretics, beta-blocker, renin-angiotensin system inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter type 2 inhibitors) as well as specific treatment for amyloidosis (e.g. tafamidis) is recorded.

  Every 3-6 months over 10 years

Secondary Outcomes (7)

• Prevalence and incidence of cardiac and non-cardiac comorbidities

  Every 3-6 months over 10 years

• New York Heart Association (NYHA) class over time

  Every 3-6 months over 10 years

• Functional capacity over time

  Every 3-6 months over 10 years

• Quality of life over time

  Every 3-6 months over 10 years

• Vital signs over time

  Every 3-6 months over 10 years

Study Arms (1)

Cardiac Amyloidosis

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

Other: Routine diagnostics; Other: Routine treatment

Interventions

Routine diagnostics OTHER

Data collection of routine diagnostics

Cardiac Amyloidosis

Routine treatment OTHER

Data collection of routine treatment

Cardiac Amyloidosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with confirmed cardiac amyloidosis who are beeing treated at Department of Cardiology at University Hospital Leipzig.

You may qualify if:

• Confirmed cardiac amyloidosis according to current standards

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Hospital Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure; Cardiomyopathy, Restrictive

Condition Hierarchy (Ancestors)

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; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies

Study Officials

• Daniel Lavall, MD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Lavall, MD

CONTACT

+493419712650; daniel.lavall@medizin.uni-leipzig.de

Romy Gessner, MD

CONTACT

+493419712650; romy.gessner@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 13, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): May 1, 2033
• Last Updated: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)