There is one clinical trial.
In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs.
Blood processing, DNA extraction, and genotyping: Blood samples will be drawn into ethylenediamenetetraacetic acid (EDTA) tubes and immediately refrigerated at 4° C. Plasma will be separated by centrifugation and stored at -80° C. DNA will be extracted from the buffy coat using a commercially available kit (Qiagen Puregene, Valencia, California) and stored at -20° C. Study participants will be genotyped for three common chr4q25 SNPs (rs2200733, rs17570669, and rs3853445) using Sanger sequencing.
[In addition, a number of exploratory analyses will be performed on other AF risk alleles, particularly the other 3 most common chr4q25 AF SNPs (rs2200733, rs17570669, rs3853445) associated with AF in EAs26 to determine if any of them modulate response to flecainide and sotalol, using the same test for the primary analysis based on the AF burden scores.
Description: Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode.Measure: AF burden (Percent of time subject is in atrial fibrillation) Time: 12 months
Description: Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned. The responses on the 20-item AFEQT are scored on a 1 to 7 Likert scale ranging from 1: "Not at all", 2:" Hardly", 3: "A little ", 4: "Moderately", 5: "Quite a bit, 6:" Very" to 7: "Extremely". A total score of 0 corresponds to complete disability, while a score of 100 describes the highest level of QualiTy-of-lifeMeasure: AF Effect on QualiTy-of-life [AFEQT] Time: 12 months