Arrhythmic Effects of Hight Dose Caffeine

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045992
• Other study ID #: 110298
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2014
• Last updated: September 24, 2014
• Start date: April 2013

Study information

• Verified date: September 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Priccila Zuchinali
• Phone: 5551 33598843
• Email: priccizuchi[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmia

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Luis Eduardo Paim Rohde	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmias		6 hours	No