Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT)
Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
The Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial Pilot Study
(AIRCRAFT Pilot) is a prospective, unblinded, pragmatic, cluster-level allocation trial.
AIRCRAFT compares two medication classes commonly used for rate control in patients in atrial
fibrillation (AF) with rapid ventricular rate (RVR). The purpose of this pilot study is to
evaluate the feasibility and approach to conducting a trial that compares the use of IV beta
blockers and IV calcium channel blockers for patients in AF with RVR in the medical intensive
care unit (MICU). AF with RVR is considered when the following parameters are met: (1)
Cardiac rhythm consistent with AF (2) Heart rate > 110 bpm. AF with RVR recurrence after
conversion to sinus rhythm or prior rate control will count as a new episode of AF with RVR.
Rate control agents will be pseudo-randomized to each of the three different MICU teams
(beta-blocker, calcium channel blocker and physician preference). Patients are admitted to
the three MICU teams on a rotating basis which will allow for pseudo-randomization, the
effects of which will be equal between the three teams. Patients will be enrolled in the
study if they develop AF with RVR and will be followed until discharge from the MICU. This
study aims to assess the adherence and fidelity to treatment assignments in the current novel
pilot study protocol which will help inform the feasibility of a larger-scale efficacy trial
between IV beta blockers and IV calcium channel blockers for initial management of AF with
RVR. Assessment of adherence and fidelity to treatment assignments in management of AF with
RVR in the MICU will help inform power calculations and the percent of patients in each study
group that received the assigned class of medication will help inform feasibility. Additional
aims include assessment of time from medication administration to rate control or sinus
conversion as well as identifying optimal means of data extraction (manual vs automated), and
incidence of adverse events including hypotension and bradycardia.