Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT)

Phase 4

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Drug: Calcium channel blocker strategy; Drug: Beta-blocker strategy; Drug: Physician preference strategy

• Registration Number: NCT04234477
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Status Verified: 2021-11
• Study Start: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-15
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium channel blocker strategy	Calcium channel blocker strategy	MICU patients assigned to Team Red will receive an intravenous (IV) calcium channel blocker strategy to manage AF with RVR
Beta-blocker strategy	Beta-blocker strategy	MICU patients assigned to Team Blue will receive an intravenous (IV) beta-blocker strategy to manage AF with RVR
Physician preference strategy	Physician preference strategy	MICU patients assigned to Team Green will receive a physician preference strategy with usual/standard of care interventions to manage AF with RVR

Primary Outcome Measures

Name	Time	Method
Adherence to assigned class of medication	6 months	The proportion of patients with AF with RVR that required rate control and were treated with their assigned class of medication. The proportion will be calculated within each group as the number of patients who received their assigned class of medication divided by the total number of patients who received any treatment for rate control of AF with RVR.

Secondary Outcome Measures

Name	Time	Method
Average number of cases of AF with RVR occurring monthly	6 months	The total number of cases of AF with RVR will be divided by the total number of MICU patients for each month of the 6 month study.
Percentage of patients who received an IV rate control agent that had AF with RVR	6 months	The number of patients who received an IV rate control agent that had AF with RVR will be divided by the total number of patients who had AF with RVR. Telemetry monitoring or EKG results will be used to identify patients with AF and RVR.

Trial Locations

Locations (1)

Boston Medical Center MICU; 🇺🇸 Boston, Massachusetts, United States