Analyzing Heart Uptake of Bone Medications in Patients with Cardiac Amyloidosis
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 2 sites (Caen and 1 other locations) |
| Trial ID | NCT04535349 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with a history of heart failure and suspected cardiac ATTR amyloidosis who meet specific clinical criteria.
Not a fit: Patients with primary amyloidosis or those with severe heart failure (NYHA class IV) may not benefit from this study.
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 performed: Other studies have shown success in using radionuclide imaging for similar conditions, indicating potential for this approach.
Eligibility criteria
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 this trial is running
Caen and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.