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

11. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

170

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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).

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Burden of premature ventricular contractions (PVCs)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-sustained ventricular tachycardia (NSVT): occurrence (%)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 (%)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jean-Benoît Le Polain de Waroux

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

11. september 2026

Først indsendt, der opfyldte QC-kriterier

11. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CUPS-ICD

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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