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NCT Number: NCT06129656

Cardiac Amyloidosis Registry of University Hospital Leipzig

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.

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Key information

Conditions

Cardiac Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Cardiomyopathies Cardiomyopathy, Restrictive Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leipzig

Leipzig, Saxony, 04103, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed cardiac amyloidosis according to current standards

Exclusion criteria

  • refusal to participate

Treatment and study plan

Routine diagnostics

Other

Data collection of routine diagnostics

Routine Treatment

Other

Data collection of routine treatment

Primary outcomes

  1. All-cause and cardiac mortality

    Time frame: 10 years

    Mortality

  2. Cumulative rate of patients with worsening heart failure

    Time frame: 10 years

    Heart failure endpoint

  3. Rate of any hospitalizations

    Time frame: 10 years

    Record of any clinical events requiring hospitalization

  4. Change in left ventricular ejection fraction

    Time frame: Every 6-12 months over 10 years

    Change in LVEF assessed by echocardiography or cardiac MRI

  5. Change in left ventricular wall thickness

    Time frame: Every 6-12 months over 10 years

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

  6. Change in systolic arterial pressure

    Time frame: Every 6-12 months over 10 years

    Change in sPAP assessed by echocardiography

  7. Change in T1 values

    Time frame: Approx. every 12 months over 10 years

    Change in T1 values assessed by cardiac MRI

  8. Change in extracellular volume values

    Time frame: Approx. every 12 months over 10 years

    Change in ECV assessed by cardiac MRI

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

    Time frame: Every 3-6 months over 10 years

    Change in serum concentration of NT-proBNP

  10. Change in high-sensitivity cardiac troponin T over time

    Time frame: Every 3-6 months over 10 years

    Change in serum concentration of hs-cTnT

  11. Changes in medical treatment for heart failure

    Time frame: Every 3-6 months over 10 years

    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.

Secondary outcomes

  1. Prevalence and incidence of cardiac and non-cardiac comorbidities

    Time frame: Every 3-6 months over 10 years

    Medical history and reports regarding any comorbidities and previous treatment will be assessed in detail at inclusion. Patients are asked for new comorbidities and new treatments at every visit.

  2. New York Heart Association (NYHA) class over time

    Time frame: Every 3-6 months over 10 years

    As parameter of clinical status

  3. Functional capacity over time

    Time frame: Every 3-6 months over 10 years

    Measured using 6 minute walk test

  4. Quality of life over time

    Time frame: Every 3-6 months over 10 years

    Measured via questionnaire (e.g. KCCQ)

  5. Vital signs over time

    Time frame: Every 3-6 months over 10 years

    Blood pressure

  6. Clinical signs of congestion over time

    Time frame: Every 3-6 months over 10 years

    E.g. edema, jugular venous distension, crackles on lung auscultation

  7. Number of cardiovascular interventions

    Time frame: Monitoring continuously over 10 years

    Indication, efficacy and safety of any cardiovascular intervention will be recorded, such as rate of pacemaker implantations, numbers of valve procedures (aortic valve implantation, mitral or tricuspid valve clipping), left atrial appendage occluder implantation, electrophysiological studies and ablation procedures

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Lavall, MD

CONTACT

[email protected]

+493419712650

Romy Gessner, MD

CONTACT

[email protected]

+493419712650

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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