Using radiotherapy to treat cardiac amyloidosis
Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study
NA · University Hospital, Geneva · NCT03397810
This study is testing if low-dose radiotherapy can help older patients with cardiac amyloidosis feel better by reducing harmful deposits in their hearts.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva (other) |
| Locations | 1 site (Geneva) |
| Trial ID | NCT03397810 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-dose external beam radiotherapy on patients with cardiac amyloidosis, a condition that leads to heart failure and has limited treatment options. Participants aged over 65 with specific cardiac symptoms and imaging results will receive targeted radiotherapy aimed at reducing amyloid deposits in the heart. The effectiveness of the treatment will be evaluated through various assessments, including cardiac imaging and quality of life measures, at a 12-week follow-up. The goal is to determine if radiotherapy can provide a new therapeutic approach for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are individuals over 65 years old with symptomatic cardiac amyloidosis and specific imaging findings.
Not a fit: Patients with certain exclusion criteria, such as those with monoclonal gammopathy or previous chest radiotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for patients suffering from cardiac amyloidosis.
How similar studies have performed: While radiotherapy has been effective for treating amyloidosis in other body parts, its application in cardiac amyloidosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Geneva
- Geneva University Hospital — Geneva, Switzerland (RECRUITING)
Study contacts
- Study coordinator: René Nkoulou, Dr.
- Email: rene.nkoulou@hcuge.ch
- Phone: +41 22 37 27 196
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.
Conditions: Amyloid Cardiomyopathy, cardiac amyloidosis, radiotherapy