What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation using antiarrhythmic drugs include amiodarone, sotalol, and dronedarone. Amiodarone can cause side effects such as thyroid dysfunction, pulmonary toxicity, liver toxicity, and skin discoloration. Sotalol may lead to bradycardia, QT interval prolongation, and the risk of torsades de pointes. Dronedarone has been associated with an increased risk of cardiovascular events, including stroke, myocardial infarction, and heart failure, particularly in patients with permanent AF. Regular monitoring is recommended to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of Atrial Fibrillation (AF). Amiodarone and sotalol are commonly used for rhythm control, with amiodarone being particularly effective but associated with significant side effects. Dronedarone, a derivative of amiodarone, was approved for maintaining sinus rhythm in patients with paroxysmal or persistent AF but is not recommended for patients with permanent AF due to increased cardiovascular risks. Flecainide and propafenone are also approved for pharmacologic conversion of AF, particularly in patients without structural heart disease. The FDA advises regular monitoring, including electrocardiograms, for patients on these medications to ensure safety and efficacy.

What other types of research exist?

Promising novel alternatives to antiarrhythmic drugs for atrial fibrillation patients include catheter ablation, which targets and destroys the heart tissue causing abnormal electrical signals, and left atrial appendage occlusion devices, which reduce stroke risk in AF patients. Additionally, advancements in hybrid surgical-catheter ablation techniques and the use of wearable cardiac monitoring devices for early detection and management of AF episodes are emerging as effective strategies.

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Sodium Channel Blocker

Antiarrhythmic Drugs for Atrial Fibrillation

Phase 4

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF

Must not have

Have already been tried on 2 or more AADs in the past for AF

Permanent AF or isolated atrial flutter

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Flecainide may include vision changes, dizziness, shortness of breath while Sotalol could cause tiredness, slow heartbeat and difficulty breathing. Both drugs might also increase risk of new arrhythmias.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had two or more episodes of AFib each month.

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I can take both Flecainide and Sotalol medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tried two or more antiarrhythmic drugs for atrial fibrillation.

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I have been diagnosed with permanent atrial fibrillation or isolated atrial flutter.

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I have used amiodarone only for a short time in the hospital.

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I have had a procedure to correct atrial fibrillation.

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I cannot take certain heart medications due to a heart condition or past heart attack.

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I cannot take certain heart medications due to a long QT interval.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AF burden (Percent of time subject is in atrial fibrillation)

Secondary study objectives

AF Effect on QualiTy-of-life [AFEQT]

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: sotalol 1stExperimental Treatment2 Interventions

sotalol x 6 months, then crossover to flecainide x 6 months

Group II: flecainide 1stExperimental Treatment2 Interventions

flecainide x 6 months, then crossover to sotalol x 6 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Flecainide

2017

Completed Phase 4

~810

Sotalol

2001

Completed Phase 3

~1440

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atrial Fibrillation (AF) involve antiarrhythmic drugs that stabilize cardiac electrical activity to prevent arrhythmias. Amiodarone and sotalol work by blocking potassium channels, which prolongs the repolarization phase and helps maintain a normal heart rhythm. Dofetilide also blocks potassium channels but is more selective, reducing the risk of arrhythmias. Flecainide and propafenone block sodium channels, slowing the conduction of electrical signals and preventing rapid, irregular heartbeats. These mechanisms are crucial for AF patients as they help tailor treatment plans to individual needs, minimizing side effects and improving the efficacy of rhythm control.