The goal of this observational study is to learn whether caffeine consumption is associated with ventricular arrhythmias and physical activity in adults with heart failure, reduced left ventricular ejection fraction, and an implantable cardioverter-defibrillator (ICD). The main questions it aims to answer are:
Is caffeine consumption associated with the burden of premature ventricular contractions (PVCs)? Is caffeine consumption associated with the occurrence of ventricular arrhythmias, including non-sustained ventricular tachycardia (NSVT), sustained monomorphic ventricular tachycardia (SMVT), and ventricular fibrillation (VF)? Is caffeine consumption associated with the level of daily physical activity recorded by the ICD?
Participants will:
Complete a one-time questionnaire about their consumption of coffee and other caffeine-containing products during the previous 7 days.
Allow researchers to collect relevant information from their medical records. Allow researchers to use data already collected during the routine follow-up of their ICD, including information on heart rhythm abnormalities, heart rate, and physical activity.
No additional hospital visits, medical examinations, blood tests, or changes to treatment are required as part of this study.
Written informed consent obtained prior to any study procedure.
Age ≥18 years.
Left ventricular systolic dysfunction (LVEF <50%), i.e. HFrEF or HFmrEF, documented on the most recent available transthoracic echocardiogram.
Presence of a transvenous implantable cardioverter-defibrillator (ICD), including cardiac resynchronization therapy defibrillators (CRT-D), implanted at least 12 months before the caffeine questionnaire.
Presence of channelopathies.
Subcutaneous implantable cardioverter-defibrillator (S-ICD), which does not provide ventricular ectopic beat counters, accelerometer-derived physical activity data or antitachycardia pacing, and therefore cannot generate the primary outcome measure.
Inability to complete the study questionnaire on coffee and caffeinated product consumption.
Patients with left ventricular systolic dysfunction (LVEF \<50%), i.e. HFrEF or HFmrEF, and an implantable cardioverter-defibrillator (ICD), including patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
Cohort
Prospective
Questionnaire
Other interventionCaffeine Consumption Questionnaire
Burden of premature ventricular contractions (PVCs)
Burden of premature ventricular contractions (PVCs), expressed as the percentage of total recorded ventricular beats represented by PVCs (%PVC burden), as provided by the device's remote monitoring software, assessed over the 12 months immediately preceding the date of the caffeine questionnaire, averaged across all monitored days. Unit: percent (%).
Non-sustained ventricular tachycardia (NSVT): occurrence (%)
Non-sustained ventricular tachycardia (NSVT). Untreated episodes of at least three consecutive ventricular beats above the programmed detection cut-off, lasting less than 30 seconds. For each episode, the device-assigned date and time will be recorded. Reported as occurrence (percentage of participants).
Non-sustained ventricular tachycardia (NSVT): rate
Non-sustained ventricular tachycardia (NSVT). Untreated episodes of at least three consecutive ventricular beats above the programmed detection cut-off, lasting less than 30 seconds. For each episode, the device-assigned date and time will be recorded. Reported as rate (episodes per 100 monitored days).
Non-sustained ventricular tachycardia (NSVT): distribution
Non-sustained ventricular tachycardia (NSVT). Untreated episodes of at least three consecutive ventricular beats above the programmed detection cut-off, lasting less than 30 seconds. For each episode, the device-assigned date and time will be recorded. Reported as the distribution of episodes across time.
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF). Episodes lasting at least 30 seconds or terminated by device therapy. Reported as occurrence (percentage of participants).
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Jean-Benoît Le Polain de Waroux
Lead sponsor
AZ Sint-Jan AV
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
