Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD

NCT07823998 · tracked via the Priya Life Science Belgium tracker

Sponsor

Jean-Benoît Le Polain de Waroux

Phase

Observational

Started

2026-10

Last updated

2026-09-17

Condition(s) studied

HFrEF - Heart Failure With Reduced Ejection FractionHFmrEFVentricular ArrhythmiaICD

Investigational drug(s) / intervention(s)

Questionnaire

Questionnaire: Caffeine Consumption Questionnaire

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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 (%).

Trial sites (1)

Facility	City	Region	Status
AZ Sint-Jan Brugge	Bruges	Belgium

Other trials for the same condition

Eccentric Muscle Training in Cardiac Rehabilitation Recruiting

Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07823998 on ClinicalTrials.gov ↗ ← All trials in Belgium