Coffee Use, Physical Activity and Symptomatic Ventricular Arrhythmias in Patients With Left Ventricular Dysfunction and an ICD (CUPS-ICD)
2026年9月11日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
170
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Bruges、ベルギー
- AZ Sint-Jan Brugge
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コンタクト：
- Dr. Jesús Diz Díaz
- 電話番号：+3250452670
- メール：cardiologie@azsintjan.be
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
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).
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Burden of premature ventricular contractions (PVCs)
時間枠：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 (%).
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12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Non-sustained ventricular tachycardia (NSVT): occurrence (%)
時間枠：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).
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12 months
|
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Non-sustained ventricular tachycardia (NSVT): rate
時間枠：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
時間枠：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
|
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Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): occurrence (%)
時間枠：12 months
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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
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Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): rate
時間枠：12 months
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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).
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12 months
|
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Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): median episode duration (seconds)
時間枠：12 months
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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).
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12 months
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Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mode of termination
時間枠：12 months
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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).
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12 months
|
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Sustained monomorphic (SMVT) and polymorphic ventricular tachycardia (PVT/VF): mean cycle length (ms)
時間枠：12 months
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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).
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12 months
|
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Physical activity (hours per day)
時間枠：12 months
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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.
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12 months
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Physical activity: mean daily activity expressed as a z-score
時間枠：12 months
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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.
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年9月11日
QC基準を満たした最初の提出物
2026年9月11日
最初の投稿 (実際)
2026年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。