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

NCT07823998 | Not Yet Recruiting

• 1 other identifier: CUPS-ICD
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

HFmrEF; Ventricular Arrhythmia; ICD; HFrEF - Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF; HFmrEF; ICD; Ventricular Arrhythmia; Caffeine consumption

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  12 months

Secondary Outcomes (10)

• Non-sustained ventricular tachycardia (NSVT): occurrence (%)

  12 months

• Non-sustained ventricular tachycardia (NSVT): rate

  12 months

• Non-sustained ventricular tachycardia (NSVT): distribution

  12 months

• Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)

  12 months

• Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate

  12 months

Interventions

Questionnaire OTHER

Caffeine Consumption Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jean-Benoît Le Polain de Waroux: lead

Study Sites (1)

AZ Sint-Jan Brugge

Bruges, Belgium

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

BE (1)