Clinical trial NCT06129656: Cardiac Amyloidosis Registry of University Hospital Leipzig
Official title: Cardiac Amyloidosis Registry of University Hospital Leipzig
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Keywords: heart failure
cardiac amyloidosis
restrictive cardiomyopathy
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed cardiac amyloidosis according to current standards

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: All-cause and cardiac mortality
timeFrame: 10 years
measure: Cumulative rate of patients with worsening heart failure
timeFrame: 10 years
measure: Rate of any hospitalizations
timeFrame: 10 years
measure: Change in left ventricular ejection fraction
timeFrame: Every 6-12 months over 10 years
measure: Change in left ventricular wall thickness
timeFrame: Every 6-12 months over 10 years
measure: Change in systolic arterial pressure
timeFrame: Every 6-12 months over 10 years
measure: Change in T1 values
timeFrame: Approx. every 12 months over 10 years
measure: Change in extracellular volume values
timeFrame: Approx. every 12 months over 10 years
measure: Change in N-Terminal Pro-B-Type Natriuretic Peptide over time
timeFrame: Every 3-6 months over 10 years
measure: Change in high-sensitivity cardiac troponin T over time
timeFrame: Every 3-6 months over 10 years
measure: Changes in medical treatment for heart failure
timeFrame: Every 3-6 months over 10 years
Secondary outcomes:
measure: Prevalence and incidence of cardiac and non-cardiac comorbidities
timeFrame: Every 3-6 months over 10 years
measure: New York Heart Association (NYHA) class over time
timeFrame: Every 3-6 months over 10 years
measure: Functional capacity over time
timeFrame: Every 3-6 months over 10 years
measure: Quality of life over time
timeFrame: Every 3-6 months over 10 years
measure: Vital signs over time
timeFrame: Every 3-6 months over 10 years
measure: Clinical signs of congestion over time
timeFrame: Every 3-6 months over 10 years
measure: Number of cardiovascular interventions
timeFrame: Monitoring continuously over 10 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Hospital Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Daniel Lavall, MD
role: PRINCIPAL_INVESTIGATOR
References: