Arrhythmic Effects of Hight Dose Caffeine

September 24, 2014 updated by: Luis Eduardo Paim Rohde

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Sub-Investigator:
          • Priccila Zuchinali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arrhythmias
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luis Eduardo Paim Rohde

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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