Patients Wanted to Test Device for Detecting Cardiac Problems in Fabry
A clinical study in the U.K. is recruiting adults with Fabry disease (FD) to determine whether implantable loop recorders (ILRs) — a device for continuous heart monitoring — can improve arrhythmia detection and identify risk predictors for cardiac problems.
Participants’ heart rhythms will be tracked, using the surgically implanted device, for three years — “giving a potential opportunity to offer treatment at an earlier stage” to Fabry patients with cardiac problems, the researchers noted. All monitoring will be done remotely.
The study, “Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients with Fabry disease: the Role of Implantable Loop Recorders (RaILRoAD),” is seeking up to 164 Fabry patients who are at least 18 years old and have evidence of heart disease. Recruitment ends Aug. 1.
Led by University Hospitals Birmingham, the RaILRoAD study (NCT03305250) is recruiting patients at its West Midlands center, as well as at the Salford Royal Hospital, in Manchester, and the Sheffield Teaching Hospitals. Two other centers in the U.K., and an additional site at the University of Sydney, in Australia, are not yet recruiting.
The open-label, randomized controlled trial is being touted as the first to evaluate arrhythmia — simply put, an irregular heartbeat — and the use of ILRs across risk profiles in Fabry cardiomyopathy. The hope is that this study will enable detailed characterization of arrhythmic risk predictors in Fabry and, ultimately, support the formulation of disease-specific guidance for high-risk patients.
The genetic disorder leads to the buildup of fat or “sphingolipid” in tissues, particularly the heart muscle. Such accumulation can disrupt the heart’s electrical conduction circuits, causing the development of abnormal heart rhythms. That, in turn, can lead to cardiac problems such as stroke, or sudden death.
Detecting cardiac problems in Fabry patients
When detected, these abnormalities — which commonly cause palpitations and blackouts but can also be asymptomatic — are typically treated with medications or the implantation of pacemakers.
To assess the need for treatment, physicians usually have patients wear a heart monitor for periods of 24 to 72 hours. A chief problem, however, is that because abnormal rhythms can be sporadic, they’re not always detected during such monitoring.
The trial, then, will aim to continually monitor and record each patient’s heart rhythms for three years using an implantable loop recorder, known as an ILR. This small, slender device — nearly the size of a AAA battery — will be placed under the skin on the chest’s left side. The outpatient procedure takes about 10 minutes, according to researchers, and uses local anesthesia.
All costs are paid by the study, the team noted, and the hospital visit for the implantation is the only one that is required during the study course.
The device connects wirelessly to the patient’s heart and will alert the hospital if an abnormality is detected. Symptomatic patients also will be able to report any signs of cardiac problems by using a provided home monitoring kit. In either case, a hospital clinician will subsequently contact the patient and the findings will be discussed. Potentially, this will provide an opportunity for earlier treatment.
Because the study aims to compare those with ILRs to those without the devices, participants will have a 50% chance of receiving it.
In addition to IRL insertion, study participants will undergo an annual electrocardiogram (ECG) and five-day 24-hour ECG monitoring via a Holter.
“We believe that more frequent use of ILRs will identify a greater burden of abnormal heart rhythms than currently detected, which will modify treatment that can reduce morbidity and mortality in this patient [group],” that National Health Services stated in a study summary. “This will also provide valuable data to inform an estimate of future risk for these patients.”
According to the summary, a recent small study indicated that the burden of abnormal heart rhythms may be underestimated in patients with advanced Fabry. In the study, the use of continuous heart monitoring with IRLs led to a significant change in treatment for 13 of 15 Fabry patients.
Those interested in joining the trial should alert their clinical team or send an email to Ashwin Roy at [email protected].
For more information about the study, send an email to Richard Steeds at [email protected].