Trial | NCT02045992  Report issue

Title

Arrhythmic Effects of Hight Dose Caffeine
Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    caffeine ...

  • Study Participants

    112
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.
Study Started
Apr 30
2013
Primary Completion
Dec 31
2015
Anticipated
Last Update
Sep 25
2014
Estimate

Dietary Supplement caffeine

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

Caffeine Experimental

Caffeine 500mg

Placebo Placebo Comparator

Lactose 500mg

Criteria 

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
No Results Posted