Clinical trial NCT04234477: Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT)
Official title: Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial Pilot Study (AIRCRAFT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: beta-blocker
calcium channel blocker
rapid ventricular rate (RVR)
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All adults admitted to the MICU at Boston Medical Center (BMC) during the study period who develop AF with RVR whose treating clinicians decides intravenous (IV) rate control agent is necessary to manage AF with RVR
* Patients readmitted to the MICU during the study period with recurrence of AF with RVR after conversion to sinus rhythm or prior rate control

Exclusion Criteria:

* Pregnancy
* Prisoners
* Allergies to study interventions
* Presentation consistent with acute asthma exacerbation
* Presentation consistent with acute systolic heart failure

Primary outcomes:
measure: Adherence to assigned class of medication
timeFrame: 6 months
Secondary outcomes:
measure: Average number of cases of AF with RVR occurring monthly
timeFrame: 6 months
measure: Percentage of patients who received an IV rate control agent that had AF with RVR
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center MICU
state: Massachusetts
Study officials:
affiliation: Pulmonary Center Boston Medical Center
name: Allan Walkey, MD
role: STUDY_DIRECTOR
References: