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Arrhythmic Effects of Hight Dose Caffeine

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ClinicalTrials.gov Identifier: NCT02045992
Recruitment Status : Unknown
Verified September 2014 by Luis Eduardo Paim Rohde, Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : January 27, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Luis Eduardo Paim Rohde, Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Arrhythmia Dietary Supplement: caffeine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial
Study Start Date : April 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Caffeine
Caffeine 500mg
Dietary Supplement: caffeine
Five doses of 100mg of caffeine diluted in 100 ml of decaffeinated coffee. One dose every hour for five hours

Placebo Comparator: Placebo
Lactose 500mg



Primary Outcome Measures :
  1. Arrhythmias [ Time Frame: 6 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045992


Contacts
Contact: Priccila Zuchinali 5551 33598843 priccizuchi@gmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Sub-Investigator: Priccila Zuchinali         
Sponsors and Collaborators
Luis Eduardo Paim Rohde
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Eduardo Paim Rohde, Professor, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02045992     History of Changes
Other Study ID Numbers: 110298
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents