Arrhythmic Effects of Hight Dose Caffeine
Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial
1 other identifier
interventional
112
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedSeptember 25, 2014
September 1, 2014
2.7 years
January 23, 2014
September 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Arrhythmias
6 hours
Study Arms (2)
Caffeine
EXPERIMENTALCaffeine 500mg
Placebo
PLACEBO COMPARATORLactose 500mg
Interventions
Five doses of 100mg of caffeine diluted in 100 ml of decaffeinated coffee. One dose every hour for five hours
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
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.
PMID: 27749954DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 23, 2014
First Posted
January 27, 2014
Study Start
April 1, 2013
Primary Completion
December 1, 2015
Last Updated
September 25, 2014
Record last verified: 2014-09