Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients With Fabry Disease (RaILRoAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03305250|
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : March 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fabry Disease||Device: Implantable Loop Recorder||Not Applicable|
This is a 3-year open-label multicentre randomised controlled trial assessing arrhythmia burden in patients with Fabry cardiac disease. This is an observational study, but with implantable loop recorder (ILR) insertion at recruitment and removal at end of trial for the intervention arm.
Null hypothesis: There will be no difference in the identification of arrhythmia between patients following standard care compared to patients following standard care but with the addition of ILR monitoring.
Beyond the proposed hypothesis, data collected will be used to inform whether ILR in FD will:
- Reveal a high burden of unrecognised arrhythmia
- Lead to frequent treatment modification (anti-coagulation, pacemaker and ICD implantation, ablation)
- Enable the development of FD specific risk prediction algorithms
- Identify predictive power of new (Troponin, BNP, lysoGB3, T1 and T2 mapping) and traditional biomarkers
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arrhythmia Burden, Risk of Sudden Cardiac Death and Stroke in Patients With Fabry Disease: the Role of Implantable Loop Recorders|
|Actual Study Start Date :||September 18, 2019|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||August 2022|
Active Comparator: Interventional Arm
Using an Implantable Loop Recorder fo continuous rhythm monitoring and home follow-up. This will be combined with standard care procedure, which will include annual ECG, 24 hour Holter/5 day ECG monitoring and further investigation dependent on symptom status.
Device: Implantable Loop Recorder
An implantable loop recorder (ILR), also known as an insertable cardiac monitor, is a small device (smaller than a AAA battery) that is inserted under the skin on the front of the chest. The ILR is inserted using local anesthetic as an out-patient procedure and lasts approximately 30 minutes. The ILR captures a continuous ECG of your heart activity, which allows doctors to detect any abnormal heart rhythms at any point. If you have the ILR, you will have the device for 3 years, after which it will be removed under local anesthetic during an out-patient procedure, again lasting approximately 30 minutes. The ILR device is completely safe and shouldn't affect your day to day living.
No Intervention: Standard of Care Arm
The standard of care with annual ECG, 24 hour Holter/5 day ECG monitoring and further investigation dependent on symptom status.
- First occurrence of atrial fibrillation (AF) requiring anticoagulation [ Time Frame: Total monitoring time period in study - 3 years ]
This will include all descriptions of AF, which can be defined as:
- paroxysmal - self-terminating episodes lasting between 48 hours to 7 days
- persistent - intermittent episodes lasting between 7 days to 1 year
- permanent - episodes lasting longer than 1 year
- First occurrence of bradyarrhythmia requiring cardiac pacing [ Time Frame: Total monitoring time period in study - 3 years ]
This would include:
- Symptomatic significant AV block.
- Mobitz type 2 AV block or complete heart block irrespective of symptoms.
- First occurrence of supraventricular arrhythmia requiring drug treatment or ablation. [ Time Frame: Total monitoring time period in study - 3 years ]
- First occurrence of non-sustained ventricular tachyarrhythmia requiring drug treatment, ICD implantation or ablation [ Time Frame: Total monitoring time period in study - 3 years ]This is classified as three or more ventricular beats at a rate >120bpm, for a duration of less than 30 seconds.
- Frequency of arrhythmia in patients with and without late gadolinium enhancement (LGE) [ Time Frame: 3 years ]The study will aim at quantifying the extent of LGE deposited with myocardial tissue on cardiac MRI scanning. This will subsequently be correlated with the burden of arrhythmia detected to assess for potential risk factors.
- Frequency of arrhythmia according to location of myocardial fibrosis (inferolateral vs. non-inferolateral) [ Time Frame: 3 years ]The study will aim to correlate the location of myocardial fibrosis with the presence or absence of cardiac arrhythmia to define location of fibrosis as a potential risk factor for arrhythmia.
- Frequency of arrhythmia in those patients with a QRS duration greater or less than 120ms [ Time Frame: 3 years ]
- Frequency of arrhythmia in those with an atrial size above or below indexed normal range for age and sex [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305250
|Contact: Ravi Vijapurapu, MD||01213716736||Ravi.Vijapurapu@uhb.nhs.uk|
|Contact: Shaun Bolton, BScfirstname.lastname@example.org|
|University of Sydney||Not yet recruiting|
|Contact: Rebecca Kozor email@example.com|
|Principal Investigator: Rebecca Kozor, MD|
|University Hospitals Birmingham NHS Foundation Trust||Recruiting|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Contact: Ravi Vijapurapu, MD 01213716736 Ravi.Vijapurapu@uhb.nhs.uk|
|Contact: Shaun Bolton, BSc 01213716795 firstname.lastname@example.org|
|Principal Investigator: Richard Steeds, MD|
|Principal Investigator: Tarekegn Hiwot, MD|
|Cambridge University Hospitals NHS Foundation Trust||Not yet recruiting|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Rosemary Rusk email@example.com|
|Principal Investigator: Rosemary Rusk, MD|
|Royal Free NHS Foundation Trust||Not yet recruiting|
|London, United Kingdom, NW3 2QG|
|Contact: Derralynn Hughes, MD firstname.lastname@example.org|
|Principal Investigator: Derralynn Hughes, MD|
|Salford Royal NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom, M6 8HD|
|Contact: Ana Jovanovic, MD Ana.Jovanovic@srft.nhs.uk|
|Principal Investigator: Ana Jovanovic, MD|
|Principal Investigator:||Richard Steeds, MD||University Hospital Birmingham NHS Foundation Trust|