Cardiac AmyloidosisNCT06129656
Cardiac Amyloidosis Registry of University Hospital Leipzig
An observational study of Cardiac Amyloidosis, run by University of Leipzig at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- Routine diagnostics and Routine treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to May 2033
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with confirmed cardiac amyloidosis who are beeing treated at Department of Cardiology at University Hospital Leipzig.
Who may be able to join
- Confirmed cardiac amyloidosis according to current standards
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Leipzig
Leipzig, Saxony, 04103
About this study
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.
Read the 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.
- Conditions
- Cardiac Amyloidosis
- Being tested
- Routine diagnostics, Routine treatment
- Keywords
- heart failure, cardiac amyloidosis, restrictive cardiomyopathy
- Medical subject headings
- Amyloid Neuropathies, Familial, Heart Failure, Cardiomyopathy, Restrictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine diagnosticsOther
Data collection of routine diagnostics
Routine treatmentOther
Data collection of routine treatment
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Amyloidosis | Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital. Receives: Other: Routine diagnostics; Other: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause and cardiac mortality
Mortality
Measured: 10 years
Cumulative rate of patients with worsening heart failure
Heart failure endpoint
Measured: 10 years
Rate of any hospitalizations
Record of any clinical events requiring hospitalization
Measured: 10 years
Change in left ventricular ejection fraction
Change in LVEF assessed by echocardiography or cardiac MRI
Measured: 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
Measured: Every 6-12 months over 10 years
Change in systolic arterial pressure
Change in sPAP assessed by echocardiography
Measured: Every 6-12 months over 10 years
Change in T1 values
Change in T1 values assessed by cardiac MRI
Measured: Approx. every 12 months over 10 years
Change in extracellular volume values
Change in ECV assessed by cardiac MRI
Measured: 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
Measured: Every 3-6 months over 10 years
Change in high-sensitivity cardiac troponin T over time
Change in serum concentration of hs-cTnT
Measured: 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.
Measured: Every 3-6 months over 10 years
Secondary outcomes (7)
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.
Measured: Every 3-6 months over 10 years
New York Heart Association (NYHA) class over time
As parameter of clinical status
Measured: Every 3-6 months over 10 years
Functional capacity over time
Measured using 6 minute walk test
Measured: Every 3-6 months over 10 years
Quality of life over time
Measured via questionnaire (e.g. KCCQ)
Measured: Every 3-6 months over 10 years
Vital signs over time
Blood pressure
Measured: Every 3-6 months over 10 years
Clinical signs of congestion over time
E.g. edema, jugular venous distension, crackles on lung auscultation
Measured: 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
Measured: Monitoring continuously over 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 May 2023
- Primary completionMay 2033 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Lavall, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129656
- Sponsor's protocol ID
- UKL_CA_registry
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Amyloidosis Registry of University Hospital Leipzig
- ClinicalTrials.gov ID
- NCT06129656
- Acronym / sponsor ID
- UKL_CA_registry
- Conditions
- Cardiac Amyloidosis
- Keywords
- heart failure, cardiac amyloidosis, restrictive cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- May 2033 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Amyloidosis | – | Other: Routine diagnostics, Other: Routine treatmentPatients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with confirmed cardiac amyloidosis who are beeing treated at Department of Cardiology at University Hospital Leipzig.
Key inclusion criteria (1 listed)
- Confirmed cardiac amyloidosis according to current standards
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine diagnosticsData collection of routine diagnostics | Other | Cardiac Amyloidosis |
| Routine treatmentData collection of routine treatment | Other | Cardiac Amyloidosis |
Primary outcome
All-cause and cardiac mortality
Time frame: 10 years
Mortality
Cumulative rate of patients with worsening heart failure
Time frame: 10 years
Heart failure endpoint
Rate of any hospitalizations
Time frame: 10 years
Record of any clinical events requiring hospitalization
Change in left ventricular ejection fraction
Time frame: Every 6-12 months over 10 years
Change in LVEF assessed by echocardiography or cardiac MRI
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
Change in systolic arterial pressure
Time frame: Every 6-12 months over 10 years
Change in sPAP assessed by echocardiography
Change in T1 values
Time frame: Approx. every 12 months over 10 years
Change in T1 values assessed by cardiac MRI
Change in extracellular volume values
Time frame: Approx. every 12 months over 10 years
Change in ECV assessed by cardiac MRI
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
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
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.
7 secondary outcomes
Prevalence and incidence of cardiac and non-cardiac comorbidities
Time frame: Every 3-6 months over 10 years
New York Heart Association (NYHA) class over time
Time frame: Every 3-6 months over 10 years
Functional capacity over time
Time frame: Every 3-6 months over 10 years
Quality of life over time
Time frame: Every 3-6 months over 10 years
Vital signs over time
Time frame: Every 3-6 months over 10 years
Clinical signs of congestion over time
Time frame: Every 3-6 months over 10 years
Number of cardiovascular interventions
Time frame: Monitoring continuously over 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Lavall, MD principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lavall, MD (+493419712650, daniel.lavall@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause and cardiac mortality (time frame: 10 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.