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Report for Clinical Trial NCT02347111

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Pilot and Feasibility Study to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

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.

NCT02347111 Atrial Fibrillation
MeSH: Atrial Fibrillation
HPO: Atrial fibrillation Paroxysmal atrial fibrillation

2 Interventions

Name: Flecainide

Description: flecainide up to 150mg twice daily for the control of atrial fibrillation

Type: Drug

flecainide 1st sotalol 1st

Name: Sotalol

Description: sotalol up to 120mg twice daily for the control of atrial fibrillation

Type: Drug

flecainide 1st sotalol 1st


Primary Outcomes

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

Time: 3 months

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 4 SNPs

SNPs


1 rs10033464

However, a SNP at the 4q25 locus (rs10033464) was significantly associated with successful symptom control (odds ratio [OR] 2.97, 95% confidence interval [CI] 1.42-6.21,


2 rs17570669

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.

Then we will create a second model that replaces the separate chr4q25 SNP terms for a combined chr4q25 risk score calculated by adding the beta-coefficients for the genotypes at rs2200733, rs17570669, and rs3853445 found in the first model.


3 rs2200733

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.

Then we will create a second model that replaces the separate chr4q25 SNP terms for a combined chr4q25 risk score calculated by adding the beta-coefficients for the genotypes at rs2200733, rs17570669, and rs3853445 found in the first model.


4 rs3853445

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.

Then we will create a second model that replaces the separate chr4q25 SNP terms for a combined chr4q25 risk score calculated by adding the beta-coefficients for the genotypes at rs2200733, rs17570669, and rs3853445 found in the first model.



HPO Nodes


HPO:
Atrial fibrillation
Genes 70
SCN4B ANK2 RYR2 LMNA PRKAG2 MYPN SCN5A TNNT2 TNNI3K TNNI3 AGPAT2 CACNA2D1 HCN4 TTN POLG2 KCNE2 KCNQ1 SGO1 FOS MYOZ2 MYH7 LMNA CAVIN1 SCN2B PLN TNNC1 MFAP5 PRKAG2 TRDN TLL1 POLG CAV1 TAB2 TMEM43 ABCC9 SLC25A4 NKX2-5 ACTN2 XK TWNK KCNJ2 DTNA RRM2B KCNJ5 CACNB2 GJA5 FLNC TBX5 SCN5A BSCL2 CSRP3 KCNA5 CACNA1C MYL4 NEXN GATAD1 DMPK KCNQ1 NPPA PPARG KCNJ2 CAVIN1 GATA5 KCNQ1 SMAD3 CASQ2 KCNH2 NUP155 SCN1B SMAD3
Paroxysmal atrial fibrillation
Genes 12
KCNJ5 SCN5A CSRP3 KCNA5 KCNJ2 SCN2B MYL4 ABCC9 TBX5 KCNE2 SCN1B PRKAG2