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. Radiotherapy has been used successfully to treat amyloidosis elsewhere in the body, however has not been tried in cardiac amyloidosis. Therefore this study aims to assess the effect of radiotherapy on cardiac amyloidosis, to evaluate whether it can successfully reduce the burden of amyloid deposits in the myocardium as assessed by 18F-Amyloid PET.
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 with administration of gadolinium and ultrasound A blood venous sample (cardiac biomarkers) Quality of life assessments
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
Geneva University Hospital
Geneva, Switzerland
RECRUITINGAssessment of the degree of amyloid
Assess intra-individual change in a quantitative measure of amyloid deposits on 18F-Amyloid (Standard Uptake Value ratio) SUVR between amyloid PET scans before and after low dose RT
Time frame: 12 weeks
Safety and adverse event associated with cardiac low dose RT
Assess the number of patients who report adverse events
Time frame: 6 months
Modification in echocardiographic global longitudinal strain
Assess intra-individual change in a quantitative measures
Time frame: 6 months
Modification in MRI extracellular volumes and T1 values
Assess intra-individual change in a quantitative measures
Time frame: 12 weeks
Modification in cardiac biomarker (ultrasensitive troponin T and BNP blood levels) features of cardiac amyloidosis
Assess intra-individual change in a quantitative measures
Time frame: 6 months
Modification of quality of life
The quality of life will be assessed by the SF-36 short form health survey quality of life scale
Time frame: 6 months
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