162 Participants Needed

Antiarrhythmic Drugs for Atrial Fibrillation

Recruiting at 3 trial locations
DD
Overseen ByDawood Darbar, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is evaluating whether a common genetic risk factor may predict how well a certain class of drugs will work for individuals with atrial fibrillation.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves testing specific antiarrhythmic drugs, you might need to adjust your current medications. It's best to discuss this with the study team.

What safety data exists for antiarrhythmic drugs like Flecainide and Sotalol used in atrial fibrillation?

Flecainide is generally safe for people with atrial fibrillation who do not have structural heart disease, but it can cause dizziness and blurred vision. Sotalol requires careful monitoring due to potential heart rhythm issues, such as QTc interval prolongation and torsades de pointes (a type of dangerous heart rhythm).12345

How do the drugs Flecainide and Sotalol differ from other treatments for atrial fibrillation?

Flecainide and Sotalol are unique in treating atrial fibrillation because they work by different mechanisms: Flecainide increases the threshold for fibrillation, making it harder for the heart to enter an irregular rhythm, while Sotalol prolongs the heart's electrical activity to maintain a normal rhythm. Sotalol is often used in patients with structural heart disease due to its lower risk of causing additional heart rhythm problems compared to some other drugs.16789

What data supports the effectiveness of the drugs Flecainide, Tambocor, Sotalol, Betapace, and Sorine for treating atrial fibrillation?

Research shows that Flecainide and Sotalol are effective in maintaining normal heart rhythm in patients with atrial fibrillation, especially when there is no significant heart disease. Sotalol, in particular, is noted for its ability to prolong the heart's electrical activity, which helps prevent irregular heartbeats.167810

Are You a Good Fit for This Trial?

This study is for adults over 18 with frequent, symptomatic atrial fibrillation who are of African, European, or Hispanic descent. Participants must be able to consent and eligible for both Flecainide and Sotalol medications. Exclusions include severe kidney or heart dysfunction, pregnant or nursing women, those with a family member in the study, recent surgery patients, individuals with certain medical conditions or contraindications to the drugs being tested.

Inclusion Criteria

I have had two or more episodes of AFib each month.
I can take both Flecainide and Sotalol medications.
Your recent heart test shows atrial fibrillation.
See 2 more

Exclusion Criteria

My atrial fibrillation is caused by a treatable condition like hyperthyroidism.
I have tried two or more antiarrhythmic drugs for atrial fibrillation.
I have been diagnosed with permanent atrial fibrillation or isolated atrial flutter.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants are randomized to receive either flecainide or sotalol for 6 months, followed by a crossover to the alternate drug for another 6 months.

12 months
Monthly visits (in-person) for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment using the Medtronic Reveal LINQ ICM system.

12 months
Continuous monitoring with ICM, periodic in-person visits

Open-label extension (optional)

Participants may opt to continue monitoring with the ICM device after the study concludes.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Flecainide
  • Sotalol
Trial Overview The trial tests two antiarrhythmic drugs (Flecainide and Sotalol) on patients with atrial fibrillation to see how genetic factors affect drug response. It's a cross-over study where participants will switch between medications so researchers can compare effects directly within the same individual.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: sotalol 1stExperimental Treatment2 Interventions
Group II: flecainide 1stExperimental Treatment2 Interventions

Flecainide is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Tambocor for:
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Approved in European Union as Tambocor for:
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Approved in Canada as Tambocor for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

Restoring and maintaining normal sinus rhythm in patients with atrial fibrillation (AF) can alleviate symptoms and potentially reduce the risk of serious complications, such as blood clots.
Antiarrhythmic agents like amiodarone and sotalol are effective in maintaining sinus rhythm, especially in patients with structural heart disease, and they have a lower risk of causing harmful arrhythmias when used correctly.
Antiarrhythmic agents for atrial fibrillation: focus on prolonging atrial repolarization.Singh, BN., Mody, FV., Lopez, B., et al.[2019]
In a study of 92 patients with recent onset atrial fibrillation, intravenous sotalol effectively restored sinus rhythm in 54% of patients, demonstrating its efficacy as a first-line treatment.
If sotalol was unsuccessful, the addition of intravenous flecainide led to a successful conversion to sinus rhythm in 84% of those patients, indicating that a combination approach can be highly effective.
Treatment of recent onset atrial fibrillation with intravenous sotalol and/or flecainide.Peters, FP., Braat, SH., Heymeriks, J., et al.[2019]
Class I antiarrhythmic agents like quinidine and flecainide, while effective for atrial fibrillation, have been associated with increased mortality and proarrhythmic effects, raising concerns about their safety in certain patients.
Sotalol, a class III antiarrhythmic drug, is increasingly used for treating atrial fibrillation due to its ability to prolong action potentials and refractory periods, with effective oral doses ranging from 80 to 320 mg every 12 hours, and it has shown promising results in clinical studies.
[Therapy of atrial fibrillation with class III anti-arrhythmia agents].Follath, F., Candinas, R., Frielingsdorf, J.[2013]

Citations

Antiarrhythmic agents for atrial fibrillation: focus on prolonging atrial repolarization. [2019]
Treatment of recent onset atrial fibrillation with intravenous sotalol and/or flecainide. [2019]
[Therapy of atrial fibrillation with class III anti-arrhythmia agents]. [2013]
Outpatient Initiation of Sotalol in Patients with Atrial Fibrillation: Utility of Cardiac Implantable Electronic Devices for Therapy Monitoring. [2021]
New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance. [2019]
Mortality and ventricular arrhythmias in patients on d,l-sotalol for rhythm control of atrial fibrillation: A nationwide cohort study. [2023]
Safety of flecainide. [2021]
Flecainide-metoprolol combination reduces atrial fibrillation clinical recurrences and improves tolerability at 1-year follow-up in persistent symptomatic atrial fibrillation. [2017]
[A comparison between flecainide and sotalol in the prevention of recurrences of paroxysmal atrial fibrillation]. [2013]
Effects of flecainide on atrial and ventricular stimulation thresholds to repetitive extrasystoles and fibrillation and on "2nd Phase" ventricular arrhythmias in dogs. [2013]
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