- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397810
Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study
May 7, 2021 updated by: Philippe Meyer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 with administration of gadolinium and ultrasound A blood venous sample (cardiac biomarkers) Quality of life assessments
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: René Nkoulou, Dr.
- Phone Number: +41 22 37 27 196
- Email: rene.nkoulou@hcuge.ch
Study Contact Backup
- Name: Philippe Meyer, Dr.
- Phone Number: +41 22 37 27 225
- Email: philippe.meyer@hcuge.ch
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Recruiting
- Geneva University Hospital
-
Contact:
- René Nkoulou, Dr.
- Email: rene.nkoulou@hcuge.ch
-
Principal Investigator:
- René Nkoulou
-
Sub-Investigator:
- Philippe Meyer
-
Sub-Investigator:
- Thomas Zillli
-
Sub-Investigator:
- Valentina Garibotto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Singe arm
Subjects will receive a low dose radiotherapy focused to the heart
|
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the degree of amyloid
Time Frame: 12 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and adverse event associated with cardiac low dose RT
Time Frame: 6 months
|
Assess the number of patients who report adverse events
|
6 months
|
Modification in echocardiographic global longitudinal strain
Time Frame: 6 months
|
Assess intra-individual change in a quantitative measures
|
6 months
|
Modification in MRI extracellular volumes and T1 values
Time Frame: 12 weeks
|
Assess intra-individual change in a quantitative measures
|
12 weeks
|
Modification in cardiac biomarker (ultrasensitive troponin T and BNP blood levels) features of cardiac amyloidosis
Time Frame: 6 months
|
Assess intra-individual change in a quantitative measures
|
6 months
|
Modification of quality of life
Time Frame: 6 months
|
The quality of life will be assessed by the SF-36 short form health survey quality of life scale
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2019
Primary Completion (Anticipated)
February 28, 2026
Study Completion (Anticipated)
February 28, 2026
Study Registration Dates
First Submitted
January 4, 2018
First Submitted That Met QC Criteria
January 11, 2018
First Posted (Actual)
January 12, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00640
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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