Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

11 septembre 2026 mis à jour par: Jean-Benoît Le Polain de Waroux

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

170

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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).

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Burden of premature ventricular contractions (PVCs)
Délai: 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 (%).
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Non-sustained ventricular tachycardia (NSVT): occurrence (%)
Délai: 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).
12 months
Non-sustained ventricular tachycardia (NSVT): rate
Délai: 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).
12 months
Non-sustained ventricular tachycardia (NSVT): distribution
Délai: 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.
12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)
Délai: 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).
12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate
Délai: 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).
12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): median episode duration (seconds)
Délai: 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).
12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mode of termination
Délai: 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).
12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms)
Délai: 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).
12 months
Physical activity (hours per day)
Délai: 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.
12 months
Physical activity: mean daily activity expressed as a z-score
Délai: 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.
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jean-Benoît Le Polain de Waroux

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

11 septembre 2026

Première soumission répondant aux critères de contrôle qualité

11 septembre 2026

Première publication (Réel)

17 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CUPS-ICD

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner