Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 22, 2023
Date Accepted: Nov 24, 2023
Prolonged mHealth-based arrhythmia monitoring in patients with hypertrophic cardiomyopathy (HCM-PATCH): Protocol for a Single-Center Cohort Study
ABSTRACT
Background:
Patients with hypertrophic cardiomyopathy (HCM) are at increased risk of sudden cardiac death (SCD) due to ventricular arrhythmias (VA) and other arrhythmias. Screening for arrhythmias is mandatory to assess the individual SCD risk but long-term electrocardiography (ECG) is rarely performed in routine clinical practice. Intensified monitoring may increase the detection rate of VA and identify more patients with an increased SCD risk who are potential candidates for primary preventive implantation of a cardioverter-defibrillator (ICD). To date, reliable data on the clinical benefit of prolonged arrhythmia monitoring in HCM patients are rare.
Objective:
This prospective study aims to measure the prevalence of ventricular arrhythmias (VA) in patients with HCM observed by mHealth-based continuous rhythm monitoring over 14 days compared to standard practice (24- and 48-h long-term ECG).
Methods:
Following the sample size calculation, 34 patients with a low or intermediate risk for SCD assessed by the HCM-Risk SCD calculator will need to be recruited in this single-center cohort study between June 2023 to January 2024. All patients receive an ECG patch that records their heart activity over a 14-day period. In addition, cardiac magnetic resonance tomography (cMRI) and genetic testing data will be integrated into risk stratification. All patients will be asked to complete questionnaires about their symptoms, previous therapy, family history, and, at the end of the study, their experience of ECG patch monitoring.
Results:
The prevalence of non-sustained ventricular tachycardia (nsVT, i.e. ventricular tachycardia of >3 beats to <30 seconds at >120 beats per minute) in HCM patients at low to intermediate risk (according to the HCM Risk-SCD calculator) in additional mHealth-based prolonged rhythm monitoring is considered the primary outcome of this study. Secondary endpoints include the number of patients undergoing a change in therapeutic management (Implantation of an implantable cardioverter defibrillator (ICD), antiarrhythmic drugs) due to detected VA, the number of patients with detection of atrial fibrillation (AF, duration >30 sec), including subsequent therapeutic intervention for AF (anticoagulation, antiarrhythmic drugs, catheter ablation, etc.) due to detected AF. Furthermore, the prevalence of cardiac arrhythmias in patients with positive cMRI findings (> 5% late gadolinium enhancement) and the prevalence of cardiac arrhythmias in patients with a HCM-typical gene mutation will be measured.
Conclusions:
A prolonged mHealth-based rhythm monitoring could lead to a difference in the prevalence of arrhythmias compared to 24- and 48-h long-term ECG. This may lead to improved identification of high-risk patients and trigger therapeutic interventions that may provide better protection from SCD or AF-related complications such as embolic stroke. Clinical Trial: DRKS-ID DRKS00032144
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.