Cardiac Amyloidosis Registry of University Hospital Leipzig

Cardiac Amyloidosis Clinical Trial

Official title:

Cardiac Amyloidosis Registry of University Hospital Leipzig

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129656
• Other study ID #: UKL_CA_registry
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 2033

Study information

• Verified date: October 2023
• Source: University of Leipzig
• Contact: Daniel Lavall, MD
• Phone: +493419712650
• Email: daniel.lavall[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2033
• Est. primary completion date: May 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Confirmed cardiac amyloidosis according to current standards

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Other:
• Routine diagnostics
Data collection of routine diagnostics
• Routine treatment
Data collection of routine treatment

Locations

Country	Name	City	State
Germany	University Hospital Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause and cardiac mortality	Mortality	10 years
Primary	Cumulative rate of patients with worsening heart failure	Heart failure endpoint	10 years
Primary	Rate of any hospitalizations	Record of any clinical events requiring hospitalization	10 years
Primary	Change in left ventricular ejection fraction	Change in LVEF assessed by echocardiography or cardiac MRI	Every 6-12 months over 10 years
Primary	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
Primary	Change in systolic arterial pressure	Change in sPAP assessed by echocardiography	Every 6-12 months over 10 years
Primary	Change in T1 values	Change in T1 values assessed by cardiac MRI	Approx. every 12 months over 10 years
Primary	Change in extracellular volume values	Change in ECV assessed by cardiac MRI	Approx. every 12 months over 10 years
Primary	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
Primary	Change in high-sensitivity cardiac troponin T over time	Change in serum concentration of hs-cTnT	Every 3-6 months over 10 years
Primary	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	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
Secondary	New York Heart Association (NYHA) class over time	As parameter of clinical status	Every 3-6 months over 10 years
Secondary	Functional capacity over time	Measured using 6 minute walk test	Every 3-6 months over 10 years
Secondary	Quality of life over time	Measured via questionnaire (e.g. KCCQ)	Every 3-6 months over 10 years
Secondary	Vital signs over time	Blood pressure	Every 3-6 months over 10 years
Secondary	Clinical signs of congestion over time	E.g. edema, jugular venous distension, crackles on lung auscultation	Every 3-6 months over 10 years
Secondary	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