drugset / Trial / NCT02710669
New Formulations of Propafenone to Treat Atrial Fibrillation
Phase 1/2
Terminated
193 enrolled
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will randomize participants to (R)-propafenone, (S)-propafenone, or placebo.
Timeline
- Start
- 2016-10
- Primary completion
- 2020-03-11
- Completion
- 2020-04
Outcome
Missed primary endpoint
Stopped: “Study halted/terminated prematurely due to COVID.”
paper There was no significant difference between (R)-propafenone and (S)-propafenone PMID 36166682 ↗
paper for the primary outcome of AF and/or atrial flutter induction in univariable (P=0.522) PMID 36166682 ↗
Publications
- Background Faggioni M, Savio-Galimberti E, Venkataraman R, Hwang HS, Kannankeril PJ, Darbar D, Knollmann BC. Suppression of spontaneous ca elevations prevents atrial fibrillation in calsequestrin 2-null hearts. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):313-20. doi: 10.1161/CIRCEP.113.000994. Epub 2014 Feb 3.
- Shoemaker MB, Yoneda ZT, Crawford DM, Akers WS, Richardson T, Montgomery JA, Phillips S, Shyr Y, Saavedra P, Estrada JC, Kanagasundram A, Shen ST, Michaud GF, Crossley G, Ellis CR, Knollmann BC. A Mechanistic Clinical Trial Using (R)- Versus (S)-Propafenone to Test RyR2 (Ryanodine Receptor) Inhibition for the Prevention of Atrial Fibrillation Induction. Circ Arrhythm Electrophysiol. 2022 Oct;15(10):e010713. doi: 10.1161/CIRCEP.121.010713. Epub 2022 Sep 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | (R)-propafenone | Unknown | 2 mg/kg | Intravenous |
| Comparator | (S)-propafenone | Unknown | 2 mg/kg | Intravenous |