ClinicalTrials.gov record NCT07577466
Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis
Screening, Characterization, and Longitudinal Follow-up of Patients With Cardiac Amyloidosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
A prospective observational study following people who are undergoing diagnostic work-up for or have a recent diagnosis of cardiac amyloidosis. Participants receive resting and exercise cardiac MRI, magnetic resonance spectroscopy, cardiopulmonary exercise testing, pulmonary function tests, and blood biomarker tests at baseline and at 6, 12, and 24 months. Study data are collected for research and do not change routine clinical care.
What it is studying. Whether and how cardiac structure, function, metabolism, and exercise capacity change over time in people with suspected or confirmed cardiac amyloidosis, and how imaging, functional tests, and blood markers relate to clinical status and treatment.
What the researchers hope to learn. To better describe disease phenotype and progression in cardiac amyloidosis, to map how imaging, metabolic, functional, and laboratory measures change over time, and to assess relationships between those measures and treatments.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Cardiac amyloidosis is a progressive disorder caused by extracellular deposition of amyloid fibrils in the heart, leading to heart failure and impaired cardiac function. Early diagnosis and targeted therapies are essential to improve patient outcomes. This prospective, single-center study aims to longitudinally follow patients with suspected cardiac amyloidosis to characterize disease progression and assess treatment effects. Participants will undergo cardiac magnetic resonance imaging (resting and exercise stress MRI), magnetic resonance spectroscopy, cardiopulmonary exercise testing (spiroergometry) and blood testing at baseline and at 6, 12, and 24 months
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age > 18 years
- Male and female patients undergoing clinically indicated diagnostic work-up for amyloidosis or with a previously confirmed diagnosis of cardiac amyloidosis prior to initiation of therapy
- Presence of left ventricular wall thickness > 12 mm on transthoracic echocardiography and at least one "red flag" suggestive of cardiac amyloidosis (according to ESC 2021 criteria) or an otherwise clinically established suspicion of amyloidosis
- Written informed consent
Exclusion criteria
- Age < 18 years
- Contraindications to cardiac MRI (e.g., metallic foreign bodies, older-generation pacemakers, severe obesity, claustrophobia)
- Lack of written informed consent for study participation
- Inability to comply with the study procedures
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
This study is designed to longitudinally evaluate patients with cardiac amyloidosis. Patients undergoing clinically indicated diagnostic work-up for amyloidosis prior to initiation of specific therapy. Participants will undergo comprehensive baseline assessments including resting cardiac MRI, exercise stress MRI, magnetic resonance spectroscopy, pulmonary function testing, cardiopulmonary exercise testing (spiroergometry) as well as blood testing including biomarkers relevant to cardiac amyloidosis (e.g., NT-proBNP, troponin, serum free light chains, immunofixation, and other routine laboratory parameters). Patients will be seen at 3 and 9 months as part of routine clinical care. Study-specific assessments, including imaging and functional testing, will be performed at 6, 12, and 24 months. Imaging, functional and laboratory findings will be correlated with clinical characteristics, laboratory parameters, and treatment over time to improve disease characterization, monitoring, and understanding of disease progression in cardiac amyloidosis. The study aims to systematically characterize cardiac structure and function, disease phenotype, and clinical status, and to assess their evolution over time. Additional data collected within the study will not influence clinical management and are intended solely for scientific analysis. The overall objective is to improve understanding of disease progression and treatment effects through comprehensive phenotyping and follow-up in a real-world clinical setting
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will have a baseline visit and repeated study assessments at 6, 12, and 24 months, plus routine clinical visits at about 3 and 9 months. Study assessments include resting cardiac MRI, exercise (stress) cardiac MRI, magnetic resonance spectroscopy, lung function tests, cardiopulmonary exercise testing (spiroergometry), and blood tests for biomarkers relevant to cardiac amyloidosis (for example NT‑proBNP, troponin, serum free light chains) and routine labs. The study will collect and analyze imaging, functional, and laboratory data over time; these additional study tests are for research and will not change clinical care. Participation requires the ability to undergo MRI and to attend scheduled study visits and tests.
How the study is structured. Prospective, single-center observational cohort study. Participants have baseline research tests (resting and exercise cardiac MRI, MR spectroscopy, pulmonary function, cardiopulmonary exercise testing, and blood tests) and repeat study-specific assessments at 6, 12, and 24 months, with routine clinical visits at 3 and 9 months. Collected measurements will be compared over time and correlated with clinical data and treatments. Study procedures do not direct clinical care.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Jun 15, 2026 (estimated)
- Primary completion
- Dec 31, 2029 (estimated)
- Study completion
- Dec 31, 2029 (estimated)
- Target enrollment
- 200 participants (estimated)
- Last updated on registry
- May 11, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Fabian Voß, MD 📞 02118105187 ✉ ctu@med.uni-duesseldorf.de
- Saskia Pietrucha, M.Sc. ✉ ctu@med.uni-duesseldorf.de
Participating sites (1)
- University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225 · Germany
- Fabian Voß, MD · 02118105187 · ctu@med.uni-duesseldorf.de
- Saskia Pietrucha, M.Sc. · + 49211 81 05187 · ctu@med.uni-duesseldorf.de
- Fabian Voß, MD
Terms used on this page · explanations by MedicalUpdates.ai
- magnetic resonance imaging
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- Written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- free light chains
- Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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