An interventional study of low dose radiotherapy in Amyloid Cardiomyopathy, sponsored by Philippe Meyer. Recruiting at 1 site in Switzerland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by Philippe Meyer · Not applicable, Interventional, and Treatment
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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
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
This study's planned enrollment of 36 is below the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Browse Amyloid Neuropathies, Familial studies →This is the only study on the registry with Philippe Meyer as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a low dose radiotherapy focused to the heart
Radiation: low dose radiotherapy
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
Assessment 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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Feb 2026, 83 months after the start.
Of 30 interventional studies with no phase under Amyloid Neuropathies, Familial, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's planned 83 months is above that.
How these figures are worked out, and which studies are left out of them.
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Amyloid Neuropathies, Familial →