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.
This prospective observational study follows people with suspected or diagnosed cardiac amyloidosis to track heart structure, function, and metabolism over time. Study assessments include resting and exercise cardiac MRI, MR spectroscopy, cardiopulmonary exercise testing, and blood tests at baseline and at 6, 12, and 24 months. Study data are for research and do not alter clinical care.
What it is studying. The study aims to learn how cardiac structure, function, and metabolism change over time in cardiac amyloidosis and how imaging, functional tests, and laboratory measures relate to clinical status and treatment.
What the researchers hope to learn. To systematically characterize cardiac structure, function, metabolism, and clinical phenotype in cardiac amyloidosis; to track their evolution over time; and to assess how these measures relate to treatment and disease progression.
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.
You would have a baseline visit and study-specific follow-up visits at 6, 12, and 24 months; participants may also be seen at 3 and 9 months as part of routine clinical care. At study visits you will undergo resting and exercise-stress cardiac MRI, magnetic resonance spectroscopy, pulmonary (lung) function testing, cardiopulmonary exercise testing (spiroergometry), and blood tests for cardiac-amyloidosis biomarkers. The study will collect and compare imaging, functional, and laboratory results over time for research. The record states that additional data collected for the study will not change your clinical management.
How the study is structured. An observational, prospective single-center cohort study. Participants have comprehensive baseline testing (resting and exercise cardiac MRI, MR spectroscopy, pulmonary function and exercise testing, and blood tests) and study-specific imaging and functional tests at 6, 12, and 24 months, with routine clinical visits at 3 and 9 months. No treatments are assigned by the study; additional data collected will not influence clinical management.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Amyloidosis Cardiac; Heart Failure; Cardiac MRI; Spectroscopic Analysis; Diagnosis; Phenotyping. Does it apply to my diagnosis?
- 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 ATTRv amyloidosis
This trial is also listed on this site under wild-type ATTR 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.
← Back to clinical trials