| Registry | NCT07823998, acronym CUPS-ICD |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 170 (Estimated) |
| Sponsor | Jean-Benoît Le Polain de Waroux (Other) |
| Conditions | HFrEF - Heart Failure With Reduced Ejection Fraction, HFmrEF, Ventricular Arrhythmia, ICD |
| Interventions | Questionnaire (Other) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-09-17, last updated 2026-09-17 |
| Locations | 1 site in Belgium |
Related Papers Related Patents Related Grants Related Experts
All trials for HFrEF - Heart Failure With Reduced Ejection Fraction All trials for HFmrEF All trials of Questionnaire
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.
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| AZ Sint-Jan Brugge | Bruges | Belgium |