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Caffeine for Atrial Fibrillation
N/A
Waitlist Available
Led By Dhanunjaya Lakkireddy
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Summary
This trial will study how well caffeine works compared to placebo in patients having a procedure to stop AF.
Who is the study for?
This trial is for adults aged 21-90 with new or recent onset Paroxysmal Atrial Fibrillation, who are undergoing AF ablation and can give informed consent. It's not for those with substance abuse history, severe caffeine intolerance, pregnancy, poor heart pump function (ejection fraction <50%), liver issues, or recent use of certain heart rhythm drugs.
What is being tested?
The study tests the effects of intravenous caffeine on atrial electrical properties and arrhythmia risk during pulmonary vein isolation procedures in AF patients. Participants will be randomly assigned to receive either caffeine or a placebo without knowing which one they're getting.
What are the potential side effects?
Potential side effects may include palpitations, increased heart rate, anxiety, restlessness, tremors, insomnia and gastrointestinal discomfort due to the nature of caffeine. The exact side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Atrial Fibrillation Induction
Secondary study objectives
Number of patients with Changes in conduction time
Atrial Fibrillation
Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Group assigned to receive caffeineActive Control1 Intervention
Group II: Group assigned to receive masked placeboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Kansas City Heart Rhythm Research FoundationLead Sponsor
28 Previous Clinical Trials
13,798 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
6,034 Patients Enrolled for Atrial Fibrillation
Kansas City Heart Rhythm Institute, Overland Park, KSUNKNOWN
2 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
30 Patients Enrolled for Atrial Fibrillation
Texas Cardiac Arrhythmia Institute, Austin, TX, USAUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a strong negative reaction to caffeine.Adults between 21 and 90 years old with new episodes of Paroxysmal Atrial Fibrillation will be part of the study if they are having a procedure called AF ablation.Your heart is not pumping blood effectively, with an ejection fraction less than 50%.You have a problem with your liver.You have taken amiodarone within the month before the procedure.You have used AAD (antiarrhythmic drugs) within 24 hours before the procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Group assigned to receive caffeine
- Group 2: Group assigned to receive masked placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT05464940 — N/A
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