EXCALIBUR
Research type
Research Study
Full title
Exploration of Arrhythmia Burden in Cardiac Amyloidosis using Implantable Loop Recorders
IRAS ID
256509
Contact name
Marianna Fontana
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Cardiac amyloidosis is a rare disease caused by the build-up of abnormal proteins called amyloid deposits in the heart, disrupting its normal functioning. The two main types are cardiac AL and ATTR amyloidosis. The overall life expectancy of cardiac amyloidosis remains poor despite the best available medical treatment, reflecting the complex nature of the disease. One common cause of death in these patients is abnormal heart beats or rhythms (called arrhythmias). We hypothesise that amyloid deposition in the heart is linked with an increased risk of life-threatening arrhythmias. Therefore we plan to insert small heart monitors called implantable loop recorders (ILRs) under the skin in the chests of patients with AL and ATTR amyloidosis. The ILR continuously monitors heart rhythm. This heart rhythm information will be downloaded at the Royal Free Hospital (RFH) cardiology department; any arrhythmias picked up will be flagged up to the study doctors. Patients and caregivers will also be taught how to manually download and transmit information from the ILR to the RFH if the patient has any heart symptoms. If any potentially dangerous arrhythmias are detected, patients will be asked to attend their local hospital or the Royal Free for appropriate treatment. Potentially eligible patients will be approached either when they attend the National Amyloidosis Centre (NAC) for a routine clinic visit or over the telephone before a clinic visit. They will have a verbal explanation and will be given the participant information sheet (PIS). Patients will have as much time as they need to consider taking part. Those who agree to participate will have the ILR inserted in clinic. After the ILR is inserted, all participants will have routine clinical follow-up throughout the study period. Participants will remain in the study for 3 years, but will be free to withdraw at any time.
REC name
North of Scotland Research Ethics Committee 2
REC reference
20/NS/0038
Date of REC Opinion
9 Apr 2020
REC opinion
Further Information Favourable Opinion