Systemic AmyloidosisAMYREGNCT07689331
Hungarian National Systemic Amyloidosis Registry
An observational study of Systemic Amyloidosis and ATTR Amyloidosis, run by Semmelweis University at 12 sites in Hungary.
Trial summary
This registry is an observational, multicenter, retrospective and prospective, non-pharmacological study designed to collect and analyze data from patients with systemic amyloidosis treated in inpatient and outpatient cardiology, hematology, nephrology, and neurology departments across Hungary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Amyloidosis, ATTR Amyloidosis, AL Amyloidosis
- How many people
- 300 participants
- Where
- 12 sitesHungary
- Study dates
- 8 Mar 2026to May 2028
- How long will I take part?
- 3 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with systemic amyloidosis in Hungary
Who may be able to join
- Diagnosis of systemic amyloidosis
- Patients aged ≥18 years at the time of enrollment
- Signed informed consent form by the patient
- Treating physician's consent
- Availability of accessible medical history
Who cannot join
- Lack of informed consent in the prospective study
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Hungary12 sites, 12 recruiting
- Recruiting
Balatonfüredi Állami Szívkórház
Balatonfüred, 8230
- Recruiting
Budapesti Szent Margit Kórház
Budapest, 1032
- Recruiting
Budapesti Péterfy Sándor utcai Kórház - Rendelőintézet
Budapest, 1076
- Recruiting
Department of Internal Medicine and Hematology, Semmelweis University
Budapest, 1088
Zoltan Pozsonyi, MD, PhD, +36208250944, pozsonyi.zoltan@semmelweis.hu
Daniella Nagy, MD, +36206701243, nagydana27@gmail.com
- Recruiting
Gottsegen National Cardiovascular Center
Budapest, 1096
- Recruiting
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest, 1097
- Recruiting
Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház
Budapest, 1115
- Recruiting
Észak-Pesti Centrumkórház - Honvédkórház
Budapest, 1134
- Recruiting
Clinical Centre, University of Debrecen
Debrecen, 4032
- Recruiting
Pécsi Tudományegyetem
Pécs, 7623
- Recruiting
Szegedi Tudományegyetem
Szeged, 6725
- Recruiting
Fejér Vármegyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000
About this study
Official title: Hungarian National Systemic Amyloidosis Registry (AMYREG) - A Multi-Center, Longitudinal, Observational Survey of Patients With Systemic Amyloidosis
This registry is an observational, multicenter, retrospective and prospective, non-pharmacological study designed to collect and analyze data from patients with systemic amyloidosis treated in inpatient and outpatient cardiology, hematology, nephrology, and neurology departments across Hungary. The registry was established in 2025.
Read the detailed description
Systemic amyloidosis is being diagnosed with increasing frequency worldwide. Owing to recent advances in diagnostic and therapeutic modalities, the disease has received growing clinical attention in recent years. Over the past two decades, the annual number of newly diagnosed light-chain amyloidosis (AL) cases has remained stable in major international amyloidosis centers, whereas the incidence of amyloid A (AA) amyloidosis has shown a progressive decline, likely attributable to the availability of modern therapies for chronic inflammatory diseases. An increasing number of patients are being diagnosed with transthyretin amyloidosis (ATTR) globally. This trend is partly related to improvements in diagnostic techniques and their broader accessibility, as well as to heightened clinical awareness among healthcare professionals. In addition, the emergence of several disease-specific therapeutic options for ATTR amyloidosis has further contributed to increased case recognition and diagnosis. The rising prevalence of systemic amyloidosis suggests that the condition may not be as rare as previously considered, but rather historically underrecognized due to limited awareness and insufficient diagnostic attention. In response to the continuously increasing number of patients, the need has emerged for a centralized national database into which data from all centers involved in the care of patients with systemic amyloidosis across Hungary can be entered.
The primary objective of this study is to characterize the demographic, epidemiological, and clinical data of patients with systemic amyloidosis in Hungary, as well as current national practices in diagnostic and therapeutic management and disease prognosis. Our long-term objective is to establish collaboration among healthcare centers involved in the care of patients with systemic amyloidosis in Hungary. This aim will be supported by the systemic amyloidosis registry (AMYREG).
The registry will include demographic data, key imaging and laboratory parameters, as well as clinically relevant disease-specific and therapeutic data for all patients diagnosed with systemic amyloidosis in Hungary. Retrospective data collection will also be possible for patients previously diagnosed, including deceased patients. This will enable the creation of a large, unified database allowing both prospective and retrospective follow-up of registered patients.
This approach will expand knowledge regarding disease course, patient survival, prognostic factors, organ involvement, diagnostic challenges, and treatment strategies across all types of systemic amyloidosis. Furthermore, it will allow assessment of the regional distribution of diagnostic practices in Hungary and characterization of the Hungarian patient population in comparison with international data. These insights are intended to improve patient care.
The study includes two patient cohorts: first, patients diagnosed with systemic amyloidosis will be prospectively enrolled from the initiation of the registry and followed longitudinally; second, patients diagnosed within the 12 months preceding study initiation may also be entered into the registry retrospectively. This is a non-interventional clinical study in which treating physicians regularly enter newly collected data from prospectively enrolled patients into the system. Data collection corresponds to secondary use of data. Patient information is provided by the treating physician. Subsequently, patients' clinical follow-up continues, and additional data may be entered retrospectively into the system.
In the future, statistical analyses will be performed on the collected data, with the aim of generating scientific conclusions and publications. Data sources include electronic health records from local hospitals and healthcare providers.
The study design is characterized by secondary use of data, in which relevant clinical events have already been collected as part of routine clinical practice for other purposes. The study involves secondary data utilization and does not include the collection or evaluation of adverse events as a study objective. Accordingly, no dedicated safety data collection is performed. However, if an investigator becomes aware of a spontaneous adverse event during the study period, it will be reported independently of the study through standard reporting procedures.
- Keywords
- ATTR, AL, systemic amyloidosis
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Amyloidosis Patients | Patients with systemic amyloidosis evaluated and treated at participating cardiology, nephrology, neurology and hematology departments in Hungary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex of Participants at Diagnosis
Sex (male or female as recorded in the medical record) of participants at the time of systemic amyloidosis diagnosis
Measured: Baseline
Age at Diagnosis
Age of participants in years at the time of systemic amyloidosis diagnosis
Measured: Baseline
Place of Residence at Diagnosis (Postal Code Level)
Participant place of residence recorded at the time of systemic amyloidosis diagnosis, reported at postal code (ZIP code) level. No street-level address information will be collected
Measured: Baseline
Treating Institution at Diagnosis
Healthcare institution where the participant received the initial diagnosis of systemic amyloidosis
Measured: Baseline
Systemic Amyloidosis Subtype at Diagnosis
Classification of systemic amyloidosis subtype (e.g., AL, ATTR, AA, or other specified subtype) as determined at the time of diagnosis according to clinical, histological, and/or laboratory criteria recorded in the medical record
Measured: Baseline
Date of Symptom Onset
Date when the first symptoms attributable to systemic amyloidosis were first documented or reported by the participant, as recorded in the medical record. Symptoms refer to clinical manifestations later attributed to systemic amyloidosis
Measured: Baseline
Date of Systemic Amyloidosis Diagnosis
Date on which systemic amyloidosis was first formally diagnosed based on clinical, histological, and/or laboratory criteria as documented in the medical record. The date corresponds to the first confirmed diagnosis recorded in the healthcare system
Measured: Baseline
Time from Symptom Onset to Systemic Amyloidosis Diagnosis (Days)
Time interval in days between first reported symptom onset attributable to systemic amyloidosis and date of first confirmed diagnosis of systemic amyloidosis. The variable is calculated as the difference between the date of symptom onset and the date of diagnosis based on medical record data
Measured: Baseline
Category of Presenting Symptom Leading to Systemic Amyloidosis Diagnosis
Categorized main presenting symptom prompting diagnostic evaluation for systemic amyloidosis, based on predefined clinical categories (cardiac, renal, neurological, gastrointestinal, constitutional, or other). Classification is based on medical record review at the time of diagnosis
Measured: Baseline
Organ Involvement at Diagnosis
Presence of organ involvement due to systemic amyloidosis at the time of diagnosis, categorized as cardiac, renal, neurological, gastrointestinal, or other involvement based on predefined clinical criteria documented in the medical record
Measured: Baseline
Biopsy Performed During Diagnostic Workup
Whether a tissue biopsy was performed during the diagnostic evaluation of systemic amyloidosis. Biopsy refers to any tissue sampling procedure (e.g., fat pad, bone marrow, or organ biopsy) performed as part of the diagnostic workup, as documented in the medical record
Measured: Baseline
Bone Scintigraphy Performed During Diagnostic Workup
Whether a bone scintigraphy study (e.g., 99mTc-PYP, 99mTc-DPD, or 99mTc-HMDP) was performed during the diagnostic evaluation of systemic amyloidosis, as documented in the medical record
Measured: Baseline
Cardiac MRI Performed During Diagnostic Workup
Whether a cardiac magnetic resonance imaging (MRI) study was performed during the diagnostic evaluation of systemic amyloidosis, as documented in the medical record
Measured: Baseline
Carpal Tunnel Syndrome Present at Diagnosis
Whether carpal tunnel syndrome was present or previously diagnosed at the time of systemic amyloidosis diagnosis, as documented in the medical record
Measured: Baseline
Polyneuropathy Disability (PND) Score at Diagnosis
Polyneuropathy Disability (PND) score at the time of systemic amyloidosis diagnosis, assessed using the standard PND classification (Grade 0-IV), as documented in the medical record. The PND score reflects the severity of peripheral neuropathy
Measured: Baseline
NT-proBNP Level at Diagnosis
Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in standard clinical units (e.g., pg/mL)
Measured: Baseline
High-sensitivity Troponin T Level at Diagnosis
Serum high-sensitivity cardiac troponin T (hs-cTnT) concentration measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in standard clinical units (e.g., ng/L)
Measured: Baseline
Estimated Glomerular Filtration Rate (eGFR) at Diagnosis
Estimated glomerular filtration rate (eGFR) measured at the time of systemic amyloidosis diagnosis, calculated using a standardized equation (e.g., CKD-EPI), as recorded in the medical record. Values are reported in mL/min/1.73 m²
Measured: Baseline
Serum Kappa Free Light Chain Level at Diagnosis
Serum concentration of kappa free light chains measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in mg/L using a standardized immunoassay
Measured: Baseline
Serum Lambda Free Light Chain Level at Diagnosis
Serum concentration of lambda free light chains measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in mg/L using a standardized immunoassay
Measured: Baseline
Serum Immunofixation Result at Diagnosis
Result of serum immunofixation electrophoresis performed at the time of systemic amyloidosis diagnosis. Results are categorized as positive or negative, and when positive, the detected monoclonal protein type (e.g., kappa, lambda, or other) is recorded as documented in the medical record
Measured: Baseline
Interventricular Septum Thickness by Echocardiography at Diagnosis
Interventricular septal thickness measured by transthoracic echocardiography during diagnostic evaluation of systemic amyloidosis. Measurement is reported in millimeters (mm) as recorded in the medical record
Measured: Baseline
Aortic Valve Stenosis Present at Diagnosis
Presence of clinically diagnosed aortic valve stenosis at the time of systemic amyloidosis diagnosis, based on echocardiographic findings and/or medical record documentation
Measured: Baseline
New York Heart Association (NYHA) Functional Class at Diagnosis
Heart failure functional status assessed using the New York Heart Association (NYHA) classification (Class I-IV) at the time of systemic amyloidosis diagnosis, as documented in the medical record
Measured: Baseline
Low Voltage on ECG at Diagnosis
Presence of low voltage QRS complexes on ECG at diagnosis
Measured: Baseline
Conduction Abnormalities on ECG at Diagnosis
Presence of conduction abnormalities (e.g., AV block, bundle branch block) on ECG at diagnosis
Measured: Baseline
Atrial Fibrillation on ECG at Diagnosis
Presence of atrial fibrillation on ECG at diagnosis
Measured: Baseline
Pharmacological Treatment for Heart Failure at Diagnosis
Presence of pharmacological treatment for heart failure at the time of systemic amyloidosis diagnosis. Heart failure therapy includes guideline-directed medical treatments such as diuretics, beta-blockers, ACE inhibitors, or ARBs, as documented in the medical record
Measured: Baseline
ATTR-specific Disease-modifying Therapy at Registry Entry
Presence of transthyretin (ATTR) amyloidosis-specific disease-modifying therapy at the time of registry enrollment (data entry). ATTR-specific therapy includes transthyretin-targeted treatments such as tafamidis or other approved disease-modifying agents, as documented in the medical record
Measured: Baseline
Genetic Testing Performed During Diagnostic Workup
Whether genetic testing (gene sequencing) was performed during the diagnostic evaluation of systemic amyloidosis, as documented in the medical record
Measured: Baseline
Genetic Testing Result and Identified Mutation
Result of genetic testing performed during diagnostic workup for systemic amyloidosis. Results are categorized as negative or positive for pathogenic variants. If positive, the specific gene mutation identified (e.g., TTR variants or other relevant pathogenic mutations) is recorded as documented in the medical record
Measured: Baseline
Secondary outcomes (2)
Mortality
Annual mortality rate
Measured: 3 years
Hospitalization
Annual hospitalization rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start8 Mar 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Systemic 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
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pozsonyi Zoltán, Semmelweis University
- Investigators
- Zoltan Pozsonyi, MD, PhD, Principal investigator, Department of Internal Medicine and Hematology, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689331
- Sponsor's protocol ID
- BM/11338-1/2025
- Acronym
- AMYREG
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends of are there any planned research projects that would justify data sharing
Publications
Jaiswal V, Agrawal V, Khulbe Y, Hanif M, Huang H, Hameed M, Shrestha AB, Perone F, Parikh C, Gomez SI, Paudel K, Zacks J, Grubb KJ, De Rosa S, Gimelli A. Cardiac amyloidosis and aortic stenosis: a state-of-the-art review. Eur Heart J Open. 2023 Oct 12;3(6):oead106. doi: 10.1093/ehjopen/oead106. eCollection 2023 Nov.
PubMed 37941729Devesa A, Camblor Blasco A, Pello Lazaro AM, Askari E, Lapena G, Gomez Talavera S, Taibo Urquia M, Rodriguez Olleros C, Tunon J, Ibanez B, Acena A. Prevalence of transthyretin amyloidosis in patients with heart failure and no left ventricular hypertrophy. ESC Heart Fail. 2021 Aug;8(4):2856-2865. doi: 10.1002/ehf2.13360. Epub 2021 May 8.
PubMed 33963812Pozsonyi Z, Pesko G, Takacs H, Csuka D, Nagy V, Szilagyi A, Hategan L, Muk B, Csanyi B, Nyolczas N, Dezsi L, Molnar JM, Csillik A, Revesz K, Ivanyi B, Szabo F, Birtalan K, Masszi T, Aranyi Z, Sepp R. Variant Transthyretin Amyloidosis (ATTRv) in Hungary: First Data on Epidemiology and Clinical Features. Genes (Basel). 2021 Jul 28;12(8):1152. doi: 10.3390/genes12081152.
PubMed 34440326Wechalekar AD, Gillmore JD, Hawkins PN. Systemic amyloidosis. Lancet. 2016 Jun 25;387(10038):2641-2654. doi: 10.1016/S0140-6736(15)01274-X. Epub 2015 Dec 21.
PubMed 26719234Ravichandran S, Lachmann HJ, Wechalekar AD. Epidemiologic and Survival Trends in Amyloidosis, 1987-2019. N Engl J Med. 2020 Apr 16;382(16):1567-1568. doi: 10.1056/NEJMc1917321. No abstract available.
PubMed 32294353
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hungarian National Systemic Amyloidosis Registry (AMYREG) - A Multi-Center, Longitudinal, Observational Survey of Patients With Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT07689331
- Acronym / sponsor ID
- AMYREG / BM/11338-1/2025
- Keywords
- ATTR, AL, systemic amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 8 Mar 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 Jul 2026 (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 registry is an observational, multicenter, retrospective and prospective, non-pharmacological study designed to collect and analyze data from patients with systemic amyloidosis treated in inpatient and outpatient cardiology, hematology, nephrology, and neurology departments across Hungary. The registry was established in 2025.
Detailed description
Systemic amyloidosis is being diagnosed with increasing frequency worldwide. Owing to recent advances in diagnostic and therapeutic modalities, the disease has received growing clinical attention in recent years. Over the past two decades, the annual number of newly diagnosed light-chain amyloidosis (AL) cases has remained stable in major international amyloidosis centers, whereas the incidence of amyloid A (AA) amyloidosis has shown a progressive decline, likely attributable to the availability of modern therapies for chronic inflammatory diseases. An increasing number of patients are being diagnosed with transthyretin amyloidosis (ATTR) globally. This trend is partly related to improvements in diagnostic techniques and their broader accessibility, as well as to heightened clinical awareness among healthcare professionals. In addition, the emergence of several disease-specific therapeutic options for ATTR amyloidosis has further contributed to increased case recognition and diagnosis. The rising prevalence of systemic amyloidosis suggests that the condition may not be as rare as previously considered, but rather historically underrecognized due to limited awareness and insufficient diagnostic attention. In response to the continuously increasing number of patients, the need has emerged for a centralized national database into which data from all centers involved in the care of patients with systemic amyloidosis across Hungary can be entered.
The primary objective of this study is to characterize the demographic, epidemiological, and clinical data of patients with systemic amyloidosis in Hungary, as well as current national practices in diagnostic and therapeutic management and disease prognosis. Our long-term objective is to establish collaboration among healthcare centers involved in the care of patients with systemic amyloidosis in Hungary. This aim will be supported by the systemic amyloidosis registry (AMYREG).
The registry will include demographic data, key imaging and laboratory parameters, as well as clinically relevant disease-specific and therapeutic data for all patients diagnosed with systemic amyloidosis in Hungary. Retrospective data collection will also be possible for patients previously diagnosed, including deceased patients. This will enable the creation of a large, unified database allowing both prospective and retrospective follow-up of registered patients.
This approach will expand knowledge regarding disease course, patient survival, prognostic factors, organ involvement, diagnostic challenges, and treatment strategies across all types of systemic amyloidosis. Furthermore, it will allow assessment of the regional distribution of diagnostic practices in Hungary and characterization of the Hungarian patient population in comparison with international data. These insights are intended to improve patient care.
The study includes two patient cohorts: first, patients diagnosed with systemic amyloidosis will be prospectively enrolled from the initiation of the registry and followed longitudinally; second, patients diagnosed within the 12 months preceding study initiation may also be entered into the registry retrospectively. This is a non-interventional clinical study in which treating physicians regularly enter newly collected data from prospectively enrolled patients into the system. Data collection corresponds to secondary use of data. Patient information is provided by the treating physician. Subsequently, patients' clinical follow-up continues, and additional data may be entered retrospectively into the system.
In the future, statistical analyses will be performed on the collected data, with the aim of generating scientific conclusions and publications. Data sources include electronic health records from local hospitals and healthcare providers.
The study design is characterized by secondary use of data, in which relevant clinical events have already been collected as part of routine clinical practice for other purposes. The study involves secondary data utilization and does not include the collection or evaluation of adverse events as a study objective. Accordingly, no dedicated safety data collection is performed. However, if an investigator becomes aware of a spontaneous adverse event during the study period, it will be reported independently of the study through standard reporting procedures.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic Amyloidosis Patients | – | –Patients with systemic amyloidosis evaluated and treated at participating cardiology, nephrology, neurology and hematology departments in Hungary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with systemic amyloidosis in Hungary
Key inclusion criteria (5 listed)
- Diagnosis of systemic amyloidosis
- Patients aged ≥18 years at the time of enrollment
- Signed informed consent form by the patient
- Treating physician's consent
- Availability of accessible medical history
Key exclusion criteria (1 listed)
- Lack of informed consent in the prospective study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sex of Participants at Diagnosis
Time frame: Baseline
Sex (male or female as recorded in the medical record) of participants at the time of systemic amyloidosis diagnosis
Age at Diagnosis
Time frame: Baseline
Age of participants in years at the time of systemic amyloidosis diagnosis
Place of Residence at Diagnosis (Postal Code Level)
Time frame: Baseline
Participant place of residence recorded at the time of systemic amyloidosis diagnosis, reported at postal code (ZIP code) level. No street-level address information will be collected
Treating Institution at Diagnosis
Time frame: Baseline
Healthcare institution where the participant received the initial diagnosis of systemic amyloidosis
Systemic Amyloidosis Subtype at Diagnosis
Time frame: Baseline
Classification of systemic amyloidosis subtype (e.g., AL, ATTR, AA, or other specified subtype) as determined at the time of diagnosis according to clinical, histological, and/or laboratory criteria recorded in the medical record
Date of Symptom Onset
Time frame: Baseline
Date when the first symptoms attributable to systemic amyloidosis were first documented or reported by the participant, as recorded in the medical record. Symptoms refer to clinical manifestations later attributed to systemic amyloidosis
Date of Systemic Amyloidosis Diagnosis
Time frame: Baseline
Date on which systemic amyloidosis was first formally diagnosed based on clinical, histological, and/or laboratory criteria as documented in the medical record. The date corresponds to the first confirmed diagnosis recorded in the healthcare system
Time from Symptom Onset to Systemic Amyloidosis Diagnosis (Days)
Time frame: Baseline
Time interval in days between first reported symptom onset attributable to systemic amyloidosis and date of first confirmed diagnosis of systemic amyloidosis. The variable is calculated as the difference between the date of symptom onset and the date of diagnosis based on medical record data
Category of Presenting Symptom Leading to Systemic Amyloidosis Diagnosis
Time frame: Baseline
Categorized main presenting symptom prompting diagnostic evaluation for systemic amyloidosis, based on predefined clinical categories (cardiac, renal, neurological, gastrointestinal, constitutional, or other). Classification is based on medical record review at the time of diagnosis
Organ Involvement at Diagnosis
Time frame: Baseline
Presence of organ involvement due to systemic amyloidosis at the time of diagnosis, categorized as cardiac, renal, neurological, gastrointestinal, or other involvement based on predefined clinical criteria documented in the medical record
Biopsy Performed During Diagnostic Workup
Time frame: Baseline
Whether a tissue biopsy was performed during the diagnostic evaluation of systemic amyloidosis. Biopsy refers to any tissue sampling procedure (e.g., fat pad, bone marrow, or organ biopsy) performed as part of the diagnostic workup, as documented in the medical record
Bone Scintigraphy Performed During Diagnostic Workup
Time frame: Baseline
Whether a bone scintigraphy study (e.g., 99mTc-PYP, 99mTc-DPD, or 99mTc-HMDP) was performed during the diagnostic evaluation of systemic amyloidosis, as documented in the medical record
Cardiac MRI Performed During Diagnostic Workup
Time frame: Baseline
Whether a cardiac magnetic resonance imaging (MRI) study was performed during the diagnostic evaluation of systemic amyloidosis, as documented in the medical record
Carpal Tunnel Syndrome Present at Diagnosis
Time frame: Baseline
Whether carpal tunnel syndrome was present or previously diagnosed at the time of systemic amyloidosis diagnosis, as documented in the medical record
Polyneuropathy Disability (PND) Score at Diagnosis
Time frame: Baseline
Polyneuropathy Disability (PND) score at the time of systemic amyloidosis diagnosis, assessed using the standard PND classification (Grade 0-IV), as documented in the medical record. The PND score reflects the severity of peripheral neuropathy
NT-proBNP Level at Diagnosis
Time frame: Baseline
Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in standard clinical units (e.g., pg/mL)
High-sensitivity Troponin T Level at Diagnosis
Time frame: Baseline
Serum high-sensitivity cardiac troponin T (hs-cTnT) concentration measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in standard clinical units (e.g., ng/L)
Estimated Glomerular Filtration Rate (eGFR) at Diagnosis
Time frame: Baseline
Estimated glomerular filtration rate (eGFR) measured at the time of systemic amyloidosis diagnosis, calculated using a standardized equation (e.g., CKD-EPI), as recorded in the medical record. Values are reported in mL/min/1.73 m²
Serum Kappa Free Light Chain Level at Diagnosis
Time frame: Baseline
Serum concentration of kappa free light chains measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in mg/L using a standardized immunoassay
Serum Lambda Free Light Chain Level at Diagnosis
Time frame: Baseline
Serum concentration of lambda free light chains measured at the time of systemic amyloidosis diagnosis, as recorded in the medical record. Values are reported in mg/L using a standardized immunoassay
Serum Immunofixation Result at Diagnosis
Time frame: Baseline
Result of serum immunofixation electrophoresis performed at the time of systemic amyloidosis diagnosis. Results are categorized as positive or negative, and when positive, the detected monoclonal protein type (e.g., kappa, lambda, or other) is recorded as documented in the medical record
Interventricular Septum Thickness by Echocardiography at Diagnosis
Time frame: Baseline
Interventricular septal thickness measured by transthoracic echocardiography during diagnostic evaluation of systemic amyloidosis. Measurement is reported in millimeters (mm) as recorded in the medical record
Aortic Valve Stenosis Present at Diagnosis
Time frame: Baseline
Presence of clinically diagnosed aortic valve stenosis at the time of systemic amyloidosis diagnosis, based on echocardiographic findings and/or medical record documentation
New York Heart Association (NYHA) Functional Class at Diagnosis
Time frame: Baseline
Heart failure functional status assessed using the New York Heart Association (NYHA) classification (Class I-IV) at the time of systemic amyloidosis diagnosis, as documented in the medical record
Low Voltage on ECG at Diagnosis
Time frame: Baseline
Presence of low voltage QRS complexes on ECG at diagnosis
Conduction Abnormalities on ECG at Diagnosis
Time frame: Baseline
Presence of conduction abnormalities (e.g., AV block, bundle branch block) on ECG at diagnosis
Atrial Fibrillation on ECG at Diagnosis
Time frame: Baseline
Presence of atrial fibrillation on ECG at diagnosis
Pharmacological Treatment for Heart Failure at Diagnosis
Time frame: Baseline
Presence of pharmacological treatment for heart failure at the time of systemic amyloidosis diagnosis. Heart failure therapy includes guideline-directed medical treatments such as diuretics, beta-blockers, ACE inhibitors, or ARBs, as documented in the medical record
ATTR-specific Disease-modifying Therapy at Registry Entry
Time frame: Baseline
Presence of transthyretin (ATTR) amyloidosis-specific disease-modifying therapy at the time of registry enrollment (data entry). ATTR-specific therapy includes transthyretin-targeted treatments such as tafamidis or other approved disease-modifying agents, as documented in the medical record
Genetic Testing Performed During Diagnostic Workup
Time frame: Baseline
Whether genetic testing (gene sequencing) was performed during the diagnostic evaluation of systemic amyloidosis, as documented in the medical record
Genetic Testing Result and Identified Mutation
Time frame: Baseline
Result of genetic testing performed during diagnostic workup for systemic amyloidosis. Results are categorized as negative or positive for pathogenic variants. If positive, the specific gene mutation identified (e.g., TTR variants or other relevant pathogenic mutations) is recorded as documented in the medical record
2 secondary outcomes
Mortality
Time frame: 3 years
Hospitalization
Time frame: 3 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 8 Jul 2026.
- Background: PubMed 37941729Jaiswal V, Agrawal V, Khulbe Y, Hanif M, Huang H, Hameed M, Shrestha AB, Perone F, Parikh C, Gomez SI, Paudel K, Zacks J, Grubb KJ, De Rosa S, Gimelli A. Cardiac amyloidosis and aortic stenosis: a state-of-the-art review. Eur Heart J Open. 2023 Oct 12;3(6):oead106. doi: 10.1093/ehjopen/oead106. eCollection 2023 Nov.
- Background: PubMed 33963812Devesa A, Camblor Blasco A, Pello Lazaro AM, Askari E, Lapena G, Gomez Talavera S, Taibo Urquia M, Rodriguez Olleros C, Tunon J, Ibanez B, Acena A. Prevalence of transthyretin amyloidosis in patients with heart failure and no left ventricular hypertrophy. ESC Heart Fail. 2021 Aug;8(4):2856-2865. doi: 10.1002/ehf2.13360. Epub 2021 May 8.
- Background: PubMed 34440326Pozsonyi Z, Pesko G, Takacs H, Csuka D, Nagy V, Szilagyi A, Hategan L, Muk B, Csanyi B, Nyolczas N, Dezsi L, Molnar JM, Csillik A, Revesz K, Ivanyi B, Szabo F, Birtalan K, Masszi T, Aranyi Z, Sepp R. Variant Transthyretin Amyloidosis (ATTRv) in Hungary: First Data on Epidemiology and Clinical Features. Genes (Basel). 2021 Jul 28;12(8):1152. doi: 10.3390/genes12081152.
- Background: PubMed 26719234Wechalekar AD, Gillmore JD, Hawkins PN. Systemic amyloidosis. Lancet. 2016 Jun 25;387(10038):2641-2654. doi: 10.1016/S0140-6736(15)01274-X. Epub 2015 Dec 21.
- Background: PubMed 32294353Ravichandran S, Lachmann HJ, Wechalekar AD. Epidemiologic and Survival Trends in Amyloidosis, 1987-2019. N Engl J Med. 2020 Apr 16;382(16):1567-1568. doi: 10.1056/NEJMc1917321. No abstract available.
- Individual participant dataSharing planned: Undecided. Depends of are there any planned research projects that would justify data sharing
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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.
Zoltan Pozsonyi, MD, PhD principal investigator
Department of Internal Medicine and Hematology, Semmelweis University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Amyloidosis and ATTR Amyloidosis, run by Semmelweis University at 12 sites in Hungary.
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 5 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Hungary. 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 Zoltan Pozsonyi, MD, PhD (+36208250944, pozsonyi.zoltan@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex of Participants at Diagnosis (time frame: Baseline). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689331, which also lists 5 linked publications.
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 8 Jul 2026.