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Coffee and Real-time Atrial and Ventricular Ectopy

NCT03671759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-10-07

No results posted yet for this study

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.

Conditions

  • Premature Atrial Contractions
  • Premature Ventricular Contractions

Interventions

BEHAVIORAL

Start: On Caffeine

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

BEHAVIORAL

Start: Off Caffeine

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

Sponsors & Collaborators

Principal Investigators

  • Gregory M Marcus, MD, MAS · University of California, San Francisco

  • David Rosenthal, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03671759 on ClinicalTrials.gov