Status:
RECRUITING
Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study
Lead Sponsor:
Philippe Meyer
Conditions:
Amyloid Cardiomyopathy
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Cardiac amyloidosis is responsible for significant morbidity associated with heart failure, and carries a poor prognosis. Currently there are very limited treatment options for this condition. Radioth...
Detailed Description
The intervention will involve administration of external beam radiotherapy (5 fractions of 2Gy) focused to the heart. Measurements of effect will be assessed at 12 weeks by: Amyloid PET Cardiac MRI ...
Eligibility Criteria
Inclusion
- Age \>65 y.o.
- Dyspnoea on exertion (NYHA II or more).
- Stable elevated cardiac enzymes (ultra sensitive Troponin T \> 14 ng/L on consecutive sampling or BNP \> 100pg/mL)
- A positive 99mTc-DPD cardiac scintigraphy (Grade 2 and 3) suggesting an ATTR or wt amyloidosis.
- Additional imaging also compatible with cardiac amyloidosis (cardiac ultrasound showing basal to apical longitudinal strain gradient and magnetic resonance imaging with elevated T1 value or extracellular volume).
- Compliance with the informed consent as attested by its signature.
- Positive baseline 18F-Florbetapir imaging, as assessed visually and quantitatively by a Tissue to Background Ratio \> 1.45
Exclusion
- Positive serum protein immunoelectrophoresis with monoclonal gammapathy.
- Previous external beam radiotherapy including the chest.
- Claustrophobia
- Presence of internal non-MR compatible devices
- Creatinine glomerular filtration rate \< 30 ml/min
- Oncologic disease (excluding skin cancer) active or in remission from less than 5 years
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03397810
Start Date
March 15 2019
End Date
February 28 2026
Last Update
May 11 2021
Active Locations (1)
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1
Geneva University Hospital
Geneva, Switzerland, 1205