Analyzing Heart Uptake of Bone Medications in Patients with Cardiac Amyloidosis
Official title: Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis
Run by University Hospital, Caen · NCT04535349 · Data updated 2026-11-12
This study is testing how well certain bone medications are taken up by the heart in patients with cardiac amyloidosis to see if it can help improve their diagnosis and treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 2 sites (Caen and 1 other locations) |
| Status | Recruiting |
| Started | October 8, 2020 |
| Main results expected | June 15, 2027 |
| Study ends | January 15, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT04535349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with a history of heart failure and suspected cardiac ATTR amyloidosis who meet specific clinical criteria.
✕Probably not a fit
Patients with primary amyloidosis or those with severe heart failure (NYHA class IV) may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the myocardial uptake of bone-seeking radiopharmaceuticals in patients diagnosed with cardiac transthyretin amyloidosis (ATTR). It aims to include 35 patients who have a suspected diagnosis of cardiac ATTR and will undergo cardiac planar radionuclide imaging as part of their routine care. The study focuses on developing quantitative methods for diagnosis, prognosis assessment, and evaluating therapeutic responses to treatments like tafamidis meglumine, which has shown promise in reducing mortality and hospitalizations. By utilizing advanced imaging techniques, the study seeks to enhance the understanding and management of this condition.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for patients with cardiac ATTR amyloidosis.
How similar studies have gone: Other studies have shown success in using radionuclide imaging for similar conditions, indicating potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement, and an increase of BNP \>200 pg/mL and/or NT-proBNP \>500 pg/mL * Suspected cardiac ATTR amyloidosis * Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm * Patient signed consent * Contraception method Exclusion Criteria: * New York Heart Association (NYHA) functional class IV despite diuretic treatment * Life expectancy \<6 month due to the severity of cardiac amyloidosis and/or comorbidities * Aortic valve surgical or percutaneous replacement within 30 days or planned within months * Presence of primary (light chain) amyloidosis * Contraindication to tafamidis * Pregnancy and breast feeding ; pregnancy test in women of reproductive age irrespective of contraception method) * Adults with protective measures
Where it's running
-
CHU de Caen
Caen, France Recruiting -
Clinique du Bois
Lille, France Recruiting
Study contacts
- Study coordinator: Damien Legallois, MD
- Email: damien.legallois@unicaen.fr
- Phone: 33230165709
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using tiny blood particles to detect and track ATTR heart amyloidosis
This project will test whether tiny blood particles called extracellular vesicles can help detect and track transthyretin (ATTR) amyloid cardiomyopathy in people with or at risk for ATTR.
-
Acoramidis for ATTR-CM: Cardiac Imaging Study
This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.
-
Long-term safety of eplontersen in adults with transthyretin amyloidosis, including those with prior liver transplant or severe liver impairment
This study will see if eplontersen remains safe over time for adults with transthyretin amyloidosis, including people who have had a liver transplant or have severe liver problems.
-
Annular ligament biopsy during endoscopic carpal tunnel surgery to screen for transthyretin amyloidosis
This study tests whether a biopsy of the annular ligament during carpal tunnel surgery can reliably indicate transthyretin amyloidosis and match the results of the standard synovial biopsy.
-
Eplontersen exposure during pregnancy and breastfeeding: outcomes
This project collects reports to see if exposure to eplontersen during pregnancy or breastfeeding affects mothers, fetuses, or infants with transthyretin amyloidosis.
-
Preventing transthyretin amyloidosis in young carriers of a genetic variant
This study is testing if a medication called acoramidis can help prevent transthyretin amyloidosis in young adults who carry a specific genetic variant that puts them at risk for the disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.