CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Start: On Caffeine +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03671759
NCT03671759N/ACompleted

Coffee and Real-time Atrial and Ventricular Ectopy

University of California, San Francisco·interventional·Posted Sep 14, 2018·Updated Oct 7, 2022

In Brief

A clinical study evaluating Start: On Caffeine and Start: Off Caffeine for Premature Atrial Contractions and Premature Ventricular Contractions. Completed, enrolled 108 participants across 1 site.

Detailed Summary

Atrial fibrillation (AF) and heart failure (HF) are morbid, costly, and incompletely understood diseases that have reached epidemic proportions worldwide. A dose-dependent relationship exists between premature atrial and ventricular contractions (PACs and PVCs) and development of AF and HF, respectively. Identifying and understanding the mechanisms of additional modifiable risk factors for ectopy has the potential to markedly reduce the healthcare burden of these diseases. In considering how to modify the prevalence of these ectopic beats, the investigators believe common exposures in daily life are prime candidates. Current guidelines suggest that caffeine may be an important trigger for frequent ectopy, although large population-based studies have not demonstrated an association between caffeine consumption and development of clinically significant arrhythmias. No study has employed an actual randomization intervention to assess the effects of caffeine on cardiac ectopy. Utilizing the Eureka platform, the investigators plan to utilize the N-of-1 strategy to rigorously investigate the real-time effect of caffeine intake on ectopy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartMay 1, 2019
Primary CompletionMar 25, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.8 years ago

Interventions

Start: On Caffeinebehavioral

In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.

Start: Off Caffeinebehavioral

In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.