Arrhythmic Effects of Hight Dose Caffeine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Caffeine

Caffeine 500mg

Group Type EXPERIMENTAL

caffeine

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Lactose 500mg

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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caffeine

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No