NCT03397810

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

7 years

First QC Date

January 4, 2018

Last Update Submit

May 7, 2021

Conditions

Amyloid Cardiomyopathy

Keywords

cardiac amyloidosisradiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (5)

  • Safety and adverse event associated with cardiac low dose RT

    6 months

  • Modification in echocardiographic global longitudinal strain

    6 months

  • Modification in MRI extracellular volumes and T1 values

    12 weeks

  • Modification in cardiac biomarker (ultrasensitive troponin T and BNP blood levels) features of cardiac amyloidosis

    6 months

  • Modification of quality of life

    6 months

Study Arms (1)

Singe arm

EXPERIMENTAL

Subjects will receive a low dose radiotherapy focused to the heart

Radiation: low dose radiotherapy

Interventions

low dose radiotherapyRADIATION

10 Gy in 5 fractions of 2 Gy on 5 consecutive days

Singe arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

René Nkoulou, Dr.

CONTACT

+41 22 37 27 196rene.nkoulou@hcuge.ch

Philippe Meyer, Dr.

CONTACT

+41 22 37 27 225philippe.meyer@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 12, 2018

Study Start

March 15, 2019

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

CH(1)