HFmrEF, HFrEF - Heart Failure With Reduced Ejection Fraction, ICD, Ventricular Arrhythmia
Conditions
Keywords
HFrEF, HFmrEF, ICD, Ventricular Arrhythmia, Caffeine consumption
Brief summary
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.
Interventions
OTHERQuestionnaire
Caffeine Consumption Questionnaire
Sponsors
Jean-Benoît Le Polain de Waroux
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained prior to any study procedure. 2. Age ≥18 years. 3. Left ventricular systolic dysfunction (LVEF \<50%), i.e. HFrEF or HFmrEF, documented on the most recent available transthoracic echocardiogram. 4. Presence of a transvenous implantable cardioverter-defibrillator (ICD), including cardiac resynchronization therapy defibrillators (CRT-D), implanted at least 12 months before the caffeine questionnaire.
Exclusion criteria
1. Presence of channelopathies. 2. 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. 3. Inability to complete the study questionnaire on coffee and caffeinated product consumption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burden of premature ventricular contractions (PVCs) | 12 months | 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 (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-sustained ventricular tachycardia (NSVT): occurrence (%) | 12 months | 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 | 12 months | 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 | 12 months | 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 (%) | 12 months | 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). |
| Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate | 12 months | Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF). Episodes lasting at least 30 seconds or terminated by device therapy. Reported as rate (episodes per 100 monitored days). |
| Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): median episode duration (seconds) | 12 months | Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF). Episodes lasting at least 30 seconds or terminated by device therapy. Reported as median episode duration (seconds). |
| Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mode of termination | 12 months | Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF). Episodes lasting at least 30 seconds or terminated by device therapy. Reported as mode of termination (percentage of episodes terminating spontaneously, by antitachycardia pacing, or by shock). |
| Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms) | 12 months | Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF). Episodes lasting at least 30 seconds or terminated by device therapy. Reported as mean cycle length (milliseconds). |
| Physical activity (hours per day) | 12 months | Physical activity, absolute. Daily physical activity recorded by the ICD accelerometer and reported by the remote monitoring platform, averaged across monitored days; platforms reporting activity as a proportion of the day are converted by multiplying by 24. Unit: hours per day. |
| Physical activity: mean daily activity expressed as a z-score | 12 months | Physical activity, manufacturer-standardised. Each participant's mean daily activity expressed as a z-score relative to the mean and standard deviation of all study participants monitored on the same platform. Unit: standard deviation units. |
Countries
Belgium
Outcome results
None listed