Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Geneva University Hospital
RECRUITING
Geneva
Contact Information
Primary
René Nkoulou, Dr.
rene.nkoulou@hcuge.ch
+41 22 37 27 196
Backup
Philippe Meyer, Dr.
philippe.meyer@hcuge.ch
+41 22 37 27 225
Time Frame
Start Date: 2019-03-15
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 36
Treatments
Experimental: Singe arm
Subjects will receive a low dose radiotherapy focused to the heart
Sponsors
Leads: Philippe Meyer

This content was sourced from clinicaltrials.gov