Hypertrophic cardiomyopathy: Clinical impact of a prolonged mHealth-based arrhythmia monitoring by single-channel ECG

Hypertrophic cardiomyopathy: Clinical impact of a prolonged mHealth-based arrhythmia monitoring by single-channel ECG - HCM-PATCH

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032144

Enrollment

Registered

2023-06-29

Start date

2023-05-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I42.1

Interventions

Group 1: HCM patients between 18 and 75 years of age without indication for cardiac implantation. During the visit to the HCM Outpatient Clinic of the Bielefeld Clinic, an ECG, stress ECG and MRI will

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Sufficient adherence as well as sufficient German language skills - Ability to give consent

Exclusion criteria

Exclusion criteria: - Pre-existing cardiac implant (event recorder, pacemaker, ICD) or already indication for it - Parkinson's disease with relevant tremor - Incapacity to give consent - current symptoms or a history of skin cancer, skin rash on skin glue, dermatosis

Design outcomes

Primary

Measure	Time frame
Prevalence of cardiac arrhythmias (nsVT, ventricular tachycardia of >3 beats to 120 bpm) in low- to intermediate-risk HCM patients* with additional mHealth-based prolonged rhythm monitoring. Data collection is performed at the beginning of study participation (d=1) and for the following 14 days by ECG patch (d=1-14). This is followed by a telephone visit with discussion of the findings (d= approx. 20).	—

Measure

Time frame

Prevalence of cardiac arrhythmias (nsVT, ventricular tachycardia of >3 beats to 120 bpm) in low- to intermediate-risk HCM patients* with additional mHealth-based prolonged rhythm monitoring. Data collection is performed at the beginning of study participation (d=1) and for the following 14 days by ECG patch (d=1-14). This is followed by a telephone visit with discussion of the findings (d= approx. 20).

—

Secondary

Measure	Time frame
- Number of patients who experience a change in therapeutic procedure (ICD implantation, antiarrhythmic drugs, etc.) due to detected nsVT in additional monitoring. - Number of patients with detection of atrial fibrillation (duration >30 sec) by prolonged monitoring. - Number of patients who experience a change in therapeutic procedure (anticoagulation, antiarrhythmic drugs, catheter ablation, etc.) due to detected atrial fibrillation - Number of female patients who experience a change in therapeutic procedure due to prolonged monitoring. - Prevalence of cardiac arrhythmias in patients with positive MRI findings (> 5% late gadolinium enhancement) - Prevalence of cardiac arrhythmias in patients with positive genetic diagnosis (detection of HCM-typical gene variants)	—

Measure

Time frame

- Number of patients who experience a change in therapeutic procedure (ICD implantation, antiarrhythmic drugs, etc.) due to detected nsVT in additional monitoring. - Number of patients with detection of atrial fibrillation (duration >30 sec) by prolonged monitoring. - Number of patients who experience a change in therapeutic procedure (anticoagulation, antiarrhythmic drugs, catheter ablation, etc.) due to detected atrial fibrillation - Number of female patients who experience a change in therapeutic procedure due to prolonged monitoring. - Prevalence of cardiac arrhythmias in patients with positive MRI findings (> 5% late gadolinium enhancement) - Prevalence of cardiac arrhythmias in patients with positive genetic diagnosis (detection of HCM-typical gene variants)

—

Countries

Germany

Contacts

Public ContactSophia Schulze Lammers

Universitätsklinik für Kardiologie und Internistische Intensivmedizin

s.schulzelammers@uni-bielefeld.de00495215813413

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026