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Cardiac Amyloidosis Registry of University Hospital Leipzig

ConditionCardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Leipzig

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed cardiac amyloidosis according to current standards

Disqualifiers

refusal to participate

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine diagnostics

    Other intervention

    Data collection of routine diagnostics

  • Routine treatment

    Other intervention

    Data collection of routine treatment

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Cardiac Amyloidosis2 interventions

Trial outcomes

Primary outcomes

1

All-cause and cardiac mortality

Mortality

Time frame
10 years
2

Cumulative rate of patients with worsening heart failure

Heart failure endpoint

Time frame
10 years
3

Rate of any hospitalizations

Record of any clinical events requiring hospitalization

Time frame
10 years
4

Change in left ventricular ejection fraction

Change in LVEF assessed by echocardiography or cardiac MRI

Time frame
Every 6-12 months over 10 years

Secondary outcomes

1

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.

Time frame
Every 3-6 months over 10 years
2

New York Heart Association (NYHA) class over time

As parameter of clinical status

Time frame
Every 3-6 months over 10 years
3

Functional capacity over time

Measured using 6 minute walk test

Time frame
Every 3-6 months over 10 years
4

Quality of life over time

Measured via questionnaire (e.g. KCCQ)

Time frame
Every 3-6 months over 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leipzig

Lead sponsor

Source ClinicalTrials.gov
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