Atrial Fibrillation study: Flecainide vs Sotalol
Official title Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
ClinicalTrials.gov ID: NCT02347111
What this study is testing
What is Flecainide?
This is an investigational medicine being studied to help control atrial fibrillation. It is designed to block certain electrical signals in the heart to help keep the rhythm steady.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a specific gene change affects how well two different types of heart rhythm drugs work.
- Who it's for
- People who have frequent, noticeable episodes of atrial fibrillation (an irregular heart rhythm).
- What's involved
- Participants will take two different heart rhythm drugs in a switch-over design, meaning they will try one drug, then switch to the other.
- Time commitment
- The source text does not specify the total duration or number of visits.
- Phase 4: studies an already-approved treatment
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- ≥ 18 years of age
- History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF
- ECG that was recorded within 1 month of randomization showing AF
- Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD
- Able to give informed consent
You likely can't join if
- Permanent AF or isolated atrial flutter
- Cardiac or thoracic surgery within the previous 6 months
- Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
- Medical condition that is likely to be fatal in less than one year
- A history of prior AF ablation
- Have already been tried on 2 or more AADs in the past for AF
See the full eligibility criteria
- ≥ 18 years of age
- History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF
- ECG that was recorded within 1 month of randomization showing AF
- Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD
- Able to give informed consent
- Permanent AF or isolated atrial flutter
- Cardiac or thoracic surgery within the previous 6 months
- Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
- Medical condition that is likely to be fatal in less than one year
- A history of prior AF ablation
- Have already been tried on 2 or more AADs in the past for AF
- Creatinine clearance \<40 ml/min
- Left ventricular ejection fraction \< 50%
- Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI
- Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc\>480 ms in females and \>460 ms in males at baseline
- A reversible cause of AF (e.g., hyperthyroidism)
- Females who are pregnant or nursing
- History of severe AV node dysfunction unless an electronic pacemaker is present
- First- or second-degree relative has already participated in the study
- Unable to adhere to study procedures that are strictly for research purposes
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.