Amyloid CardiomyopathyNCT03397810
Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study
A study testing low dose radiotherapy in people with Amyloid Cardiomyopathy, run by Philippe Meyer at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Amyloid Cardiomyopathy
- What is being tested?
- low dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2019to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospital
Geneva, 1205
René Nkoulou, Dr., rene.nkoulou@hcuge.ch
René Nkoulou
About this study
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.
Read the 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
- Conditions
- Amyloid Cardiomyopathy
- Being tested
- low dose radiotherapy
- Keywords
- cardiac amyloidosis, radiotherapy
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose radiotherapyRadiation
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Singe arm | Experimental | Subjects will receive a low dose radiotherapy focused to the heart Receives: Radiation: low dose radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (5)
Safety and adverse event associated with cardiac low dose RT
Assess the number of patients who report adverse events
Measured: 6 months
Modification in echocardiographic global longitudinal strain
Assess intra-individual change in a quantitative measures
Measured: 6 months
Modification in MRI extracellular volumes and T1 values
Assess intra-individual change in a quantitative measures
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start15 Mar 2019
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philippe Meyer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe Meyer, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397810
- Sponsor's protocol ID
- 2017-00640
- Other IDs
- 2017
- Status last verified
- May 2021
- First submitted
- 4 Jan 2018
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03397810
- Acronym / sponsor ID
- 2017-00640
- Conditions
- Amyloid Cardiomyopathy
- Keywords
- cardiac amyloidosis, radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Philippe MeyerUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singe arm | Experimental | Radiation: low dose radiotherapySubjects will receive a low dose radiotherapy focused to the heart |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose radiotherapy10 Gy in 5 fractions of 2 Gy on 5 consecutive days | Radiation | Singe arm |
Primary outcome
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
5 secondary outcomes
Safety and adverse event associated with cardiac low dose RT
Time frame: 6 months
Modification in echocardiographic global longitudinal strain
Time frame: 6 months
Modification in MRI extracellular volumes and T1 values
Time frame: 12 weeks
Modification in cardiac biomarker (ultrasensitive troponin T and BNP blood levels) features of cardiac amyloidosis
Time frame: 6 months
Modification of quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose radiotherapy in people with Amyloid Cardiomyopathy, run by Philippe Meyer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact René Nkoulou, Dr. (+41 22 37 27 196, rene.nkoulou@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the degree of amyloid (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.