ClinicalTrials.gov record NCT05776212
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
Quantitative-imaging in Cardiac Transthyretin 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 is a prospective, observational imaging study using 18F‑fluoride PET in people with cardiac transthyretin amyloidosis (ATTR-CM) and comparison groups (cardiac AL amyloidosis and hypertrophic cardiomyopathy). It aims to optimise the PET scan protocol, compare PET results with cardiac MRI, and follow ATTR-CM patients over time to measure change. The study also examines PET changes in relation to tafamidis treatment.
What it is studying. Whether an optimized 18F‑fluoride PET scan can (1) provide a tissue-to-background ratio (TBR) threshold that distinguishes ATTR-CM from similar conditions, (2) be calibrated against cardiac magnetic resonance (CMR) extracellular volume as a quantitative measure of ATTR burden, and (3) detect changes over time, including changes seen with tafamidis treatment.
What the researchers hope to learn. Develop and optimise 18F‑fluoride PET imaging for ATTR-CM; define a PET TBR threshold to differentiate ATTR-CM from phenocopies; calibrate PET against CMR extracellular volume as a measure of myocardial ATTR burden; and evaluate PET's ability to track disease progression and response to tafamidis over time.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM. Hypotheses:
- A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM.
- Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked.
- Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Radiation
- 18F-fluoride PET
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Completion of informed consent
- Age > 40 years for patients with ATTR or AL cardiac amyloidosis and age >30 years for patients with HCM
- ATTR cardiac amyloid according to Expert Consensus Recommendations
- AL amyloidosis according to Expert Consensus Recommendations
- Hypertrophic cardiomyopathy according to European Society of Cardiology guidelines
Exclusion criteria
- Inability or unwilling to give informed consent
- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
- Renal dysfunction (eGFR ≤30 mL/min/1.73m2)
- NYHA Class IV heart failure
- Patients with atrial fibrillation and poor rate control.
- Contraindications to MR
- Previous history of contrast allergy of adverse reactions (gadolinium)
- Contraindications to tafamidis therapy
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Studies have shown that there is calcium deposition in the heart muscle in ATTR-CM but exactly how this happens is not completely understood. Tafamidis, a new drug treatment, has shown improved outcomes for patients with ATTRCM by reducing hospitalisations and improving survival but the mechanism of action of Tafamidis is also not clearly understood yet. 18F-Fluoride PET/CT offers the opportunity to study this phenomenon of calcium deposition in ATTR-CM in more detail and study and track response to the new drug treatment. This will also provide an opportunity to investigate whether tafamidis therapy reduces calcium deposition in the heart muscle associated with ATTR-CM. We have designed the study specifically to answer our research questions as best as possible, whilst keeping burdens to the patients at a minimum. To the best of our knowledge this will be the first human study to utilise this imaging technique to assess and track response to the new drug treatment in ATTR-CM. We hope that it will provide major insights in to complex interactions at play, that could drive forward the development of novel therapeutic strategies for patients with ATTR-CM.
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 undergo 18F-fluoride PET scans (which involve a small amount of radiation) and cardiac magnetic resonance imaging (often with gadolinium contrast), have blood tests for cardiac biomarkers, complete brief clinical tests (for example a 6-minute walk) and questionnaires. Imaging and clinical assessments are done at baseline and at follow-up to track disease and treatment response (including about one year later); some outcomes may be recorded up to 2.5 years.
How the study is structured. A prospective, case-control observational study. Participants will have 18F‑fluoride PET scans; many ATTR-CM participants will also have cardiac MRI and clinical tests. The study compares PET measurements between ATTR-CM, cardiac AL amyloidosis, and hypertrophic cardiomyopathy, and follows ATTR-CM participants to track change over about one year.
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 ATTR-CM. 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 listed sites are in Netherlands. 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
- Aug 25, 2021
- Primary completion
- Sep 30, 2026 (estimated)
- Study completion
- Sep 30, 2026 (estimated)
- Target enrollment
- 140 participants (estimated)
- Last updated on registry
- Jun 27, 2025
- 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
- University of Edinburgh
- Collaborators
- British Heart Foundation
- Netherlands Heart Foundation
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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.
- Riemer Slart, MD PhD 📞 +31503611835 ✉ r.h.j.a.slart@umcg.nl
Participating sites (1)
- University Medical Centre GroningenRecruiting
Groningen, 9713 GZ · Netherlands
- Riemer HJ Slart, MD PhD · +31 50 361 1835 · r.h.j.a.slart@umcg.nl
Terms used on this page · explanations by MedicalUpdates.ai
- PET
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- 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.
- eGFR
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- 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.
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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