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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Other: Routine diagnostics; Other: Routine treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Daniel Lavall, MD; Phone Number: +493419712650; Email: daniel.lavall@medizin.uni-leipzig.de
• Study Contact Backup: Name: Romy Gessner, MD; Phone Number: +493419712650; Email: romy.gessner@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • University Hospital Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Confirmed cardiac amyloidosis according to current standards

Exclusion Criteria:

• refusal to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Amyloidosis; Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital.	Other: Routine diagnostics; Data collection of routine diagnostics; Other: Routine treatment; Data collection of routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and incidence of cardiac and non-cardiac comorbidities	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.	Every 3-6 months over 10 years
New York Heart Association (NYHA) class over time	As parameter of clinical status	Every 3-6 months over 10 years
Functional capacity over time	Measured using 6 minute walk test	Every 3-6 months over 10 years
Quality of life over time	Measured via questionnaire (e.g. KCCQ)	Every 3-6 months over 10 years
Vital signs over time	Blood pressure	Every 3-6 months over 10 years
Clinical signs of congestion over time	E.g. edema, jugular venous distension, crackles on lung auscultation	Every 3-6 months over 10 years
Number of cardiovascular interventions	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	Monitoring continuously over 10 years

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Daniel Lavall, MD, University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): May 1, 2033

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: heart failure; cardiac amyloidosis; restrictive cardiomyopathy
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: UKL_CA_registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No