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NCT Number: NCT07823998

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Questionnaire

Other

Caffeine Consumption Questionnaire

Primary outcomes

  1. Burden of premature ventricular contractions (PVCs)

    Time frame: 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 outcomes

  1. Non-sustained ventricular tachycardia (NSVT): occurrence (%)

    Time frame: 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).

  2. Non-sustained ventricular tachycardia (NSVT): rate

    Time frame: 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).

  3. Non-sustained ventricular tachycardia (NSVT): distribution

    Time frame: 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.

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

    Time frame: 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).

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

    Time frame: 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).

  6. Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): median episode duration (seconds)

    Time frame: 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).

  7. Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mode of termination

    Time frame: 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).

  8. Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms)

    Time frame: 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).

  9. Physical activity (hours per day)

    Time frame: 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.

  10. Physical activity: mean daily activity expressed as a z-score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jean-Benoît Le Polain de Waroux

Other

Registry information

Acronym: CUPS-ICD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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