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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will enroll patients with frequent episodes of atrial fibrillation in a study testing two different classes of anti arrhythmic drugs. This study will provide preliminary data for a larger study testing the hypothesis that a common AF genetic risk allele modulates response to different AADs.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AF burden (Percent of time subject is in atrial fibrillation)
Secondary outcome measures
AF Effect on QualiTy-of-life [AFEQT]

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

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
604 Previous Clinical Trials
1,558,833 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
247 Patients Enrolled for Atrial Fibrillation
MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,074 Total Patients Enrolled
64 Trials studying Atrial Fibrillation
19,109 Patients Enrolled for Atrial Fibrillation

Media Library

Flecainide (Sodium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT02347111 — Phase 4
Atrial Fibrillation Research Study Groups: flecainide 1st, sotalol 1st
Atrial Fibrillation Clinical Trial 2023: Flecainide Highlights & Side Effects. Trial Name: NCT02347111 — Phase 4
Flecainide (Sodium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02347111 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does the safety profile of flecainide compare to other treatments?

"Flecainide has an assigned safety rating of 3, since it is already approved for use in Phase 4 trials."

Answered by AI

What prior investigations have been implemented using flecainide as a primary catalyst?

"Presently, 9 trials of flecainide 1st are in progress. One is currently entering Phase 3 while the remaining studies are being administered at 61 sites located primarily within New york City."

Answered by AI

What ailments are typically addressed with flecainide?

"Flecainide 1st is the primary treatment for severe paroxysmal atrial fibrillation and it has also been used to alleviate other ailments such as paroxysmal supraventricular tachycardia, sinus rhythm, and ventricular tachycardia."

Answered by AI

To what extent is the population being examined in this exploration?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial is presently pursuing participants, which were initially posted on December 31st 2020 and edited for the last time June 23rd 2022. 162 individuals are needed to be recruited from 4 different medical facilities."

Answered by AI

Does this trial have any conditions for participation?

"To be eligible for this research, participants must have atrial fibrillation and meet the age requirements (18-100). Furthermore, only individuals of African, European or Hispanic descent can join. A total of 162 patients are being recruited."

Answered by AI

Are opportunities to participate in this research study still available?

"Affirmative. According to the clinicaltrials.gov listing, this clinical study is currently open for enrollment with a start date of December 31st 2020 and an end date of June 23rd 2022. This medical trial requires 162 participants from 4 separate sites."

Answered by AI

Is eligibility for this medical experiment limited to adults only?

"The upper age limit set by this clinical trial is 100, while the lower limit stands at 18. For those under 18, 12 trials are currently available and 481 for individuals aged over 65."

Answered by AI
~46 spots leftby Jun 2025