CClinicalTrials.gg
Status unknownNCT02045992Updated Sep 25, 2014

Arrhythmic Effects of Hight Dose Caffeine

An interventional study of caffeine in Arrhythmia, sponsored by Luis Eduardo Paim Rohde. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-25.

Sponsored by Luis Eduardo Paim Rohde · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Heart failure patients represent a group of individuals at higher risk for cardiac arrhythmias. There is a perception that caffeine consumption may represent an increase in this risk. Although the medical staff and health professionals suggest a reduction in the intake of this substance to patients considered at risk, there is no scientific proof for this recommendation.

Some animal studies suggest a possible association between arrhythmias and caffeine use with higher doses, but this finding did not appear in human studies. In particular, little is known about the association between caffeine consumption and arrhythmias in patients with heart failure, especially at higher doses of consumption.

More specific and safe guidelines on caffeine consumption are needed.

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Conditions studied

  • Arrhythmia

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03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 112 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

This is the only study on the registry with Luis Eduardo Paim Rohde as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Heart failure in NYHA functional class I-III
  • LV Ejection fraction \<45%
  • Age > 18 y.o.
  • Cardio-defibrillator implanted with normal functioning with at least 30 days.

Exclusion criteria

Exclusion Criteria:

  • Impossibility of take caffeine
  • Inability to perform an exercise test
  • Initial use of amiodarone in the last 2 months
  • Unstable ventricular arrhythmias, shock or ATP in the last 60 days
  • Hospitalization in the last two months due to decompensated heart failure
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Caffeine

    Caffeine 500mg

    Dietary Supplement: caffeine

  • Placebo comparator
    Placebo

    Lactose 500mg

Interventions

  • Dietary supplementcaffeine

    Five doses of 100mg of caffeine diluted in 100 ml of decaffeinated coffee. One dose every hour for five hours

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What researchers measure

Primary outcomes

  1. Arrhythmias

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul, Brazil
    • Priccila Zuchinali · Sub investigator
    Recruiting
08

References and documents

Publications

  • Zuchinali P, Souza GC, Pimentel M, Chemello D, Zimerman A, Giaretta V, Salamoni J, Fracasso B, Zimerman LI, Rohde LE. Short-term Effects of High-Dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure: A Randomized Clinical Trial. JAMA Intern Med. 2016 Dec 1;176(12):1752-1759. doi: 10.1001/jamainternmed.2016.6374. PubMed 27749954 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02045992
Lead sponsor
Luis Eduardo Paim Rohde
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Luis Eduardo Paim Rohde (Professor, Hospital de Clinicas de Porto Alegre) — Sponsor-investigator
First posted
Jan 27, 2014
Start date
Apr 2013
Primary completion
Dec 2015 (estimated)
Last update
Sep 25, 2014

Study contacts

Priccila Zuchinali
Contact
priccizuchi@gmail.com
5551 33598843

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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