HFrEF - Heart Failure With Reduced Ejection FractionCUPS-ICDNCT07823998
Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and HFmrEF, run by Jean-Benoît Le Polain de Waroux at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, HFmrEF, Ventricular Arrhythmia
- What is being tested?
- Questionnaire
- How many people
- 170 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
AZ Sint-Jan Brugge
Bruges
Dr. Jesús Diz Díaz, +3250452670, cardiologie@azsintjan.be
About this study
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?
Read more
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.
- Being tested
- Questionnaire
- Keywords
- HFrEF, HFmrEF, ICD, Ventricular Arrhythmia, Caffeine consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Caffeine Consumption Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 12 months
Secondary outcomes (10)
Non-sustained ventricular tachycardia (NSVT): occurrence (%)
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).
Measured: 12 months
Non-sustained ventricular tachycardia (NSVT): rate
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).
Measured: 12 months
Non-sustained ventricular tachycardia (NSVT): distribution
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.
Measured: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)
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).
Measured: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate
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).
Measured: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): median episode duration (seconds)
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).
Measured: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mode of termination
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).
Measured: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms)
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).
Measured: 12 months
Physical activity (hours per day)
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.
Measured: 12 months
Physical activity: mean daily activity expressed as a z-score
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jean-Benoît Le Polain de Waroux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-Benoît Le Polain de Waroux, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823998
- Sponsor's protocol ID
- CUPS-ICD
- Acronym
- CUPS-ICD
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD
- ClinicalTrials.gov ID
- NCT07823998
- Acronym / sponsor ID
- CUPS-ICD / CUPS-ICD
- Keywords
- HFrEF, HFmrEF, ICD, Ventricular Arrhythmia, Caffeine consumption
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Jean-Benoît Le Polain de WarouxUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireCaffeine Consumption Questionnaire | Other | – |
Primary outcome
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 (%).
10 secondary outcomes
Non-sustained ventricular tachycardia (NSVT): occurrence (%)
Time frame: 12 months
Non-sustained ventricular tachycardia (NSVT): rate
Time frame: 12 months
Non-sustained ventricular tachycardia (NSVT): distribution
Time frame: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)
Time frame: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate
Time frame: 12 months
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): mode of termination
Time frame: 12 months
Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms)
Time frame: 12 months
Physical activity (hours per day)
Time frame: 12 months
Physical activity: mean daily activity expressed as a z-score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and HFmrEF, run by Jean-Benoît Le Polain de Waroux at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of premature ventricular contractions (PVCs) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.