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Arrhythmic Effects of Hight Dose Caffeine

Primary Purpose

Arrhythmia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
caffeine
Sponsored by
Luis Eduardo Paim Rohde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine

Placebo

Arm Description

Caffeine 500mg

Lactose 500mg

Outcomes

Primary Outcome Measures

Arrhythmias

Secondary Outcome Measures

Full Information

First Posted
January 23, 2014
Last Updated
September 24, 2014
Sponsor
Luis Eduardo Paim Rohde
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02045992
Brief Title
Arrhythmic Effects of Hight Dose Caffeine
Official Title
Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis Eduardo Paim Rohde
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeine
Arm Type
Experimental
Arm Description
Caffeine 500mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lactose 500mg
Intervention Type
Dietary Supplement
Intervention Name(s)
caffeine
Intervention Description
Five doses of 100mg of caffeine diluted in 100 ml of decaffeinated coffee. One dose every hour for five hours
Primary Outcome Measure Information:
Title
Arrhythmias
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priccila Zuchinali
Phone
5551 33598843
Email
priccizuchi@gmail.com
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priccila Zuchinali

12. IPD Sharing Statement

Citations:
PubMed Identifier
27749954
Citation
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.
Results Reference
derived

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Arrhythmic Effects of Hight Dose Caffeine

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