Arrhythmic Effects of Hight Dose Caffeine

Luis Eduardo Paim Rohde

Status: Unknown

Conditions: Arrhythmia

Treatments: Dietary Supplement: caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT02045992

110298

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

112 participants in 2 patient groups, including a placebo group

Caffeine

Experimental group

Description:

Caffeine 500mg

Treatment:

Dietary Supplement: caffeine

Placebo

Placebo Comparator group

Description:

Lactose 500mg