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

NCT ID: NCT04234477

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2022-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Beta-blocker strategy

MICU patients assigned to Team Blue will receive an intravenous (IV) beta-blocker strategy to manage AF with RVR

Group Type: EXPERIMENTAL

Beta-blocker strategy

Intervention Type: DRUG

Clinicians within the intervention groups will be free to use whatever dosing amount and frequency of their assigned medication class that they deem as medically appropriate, including the decision to use intermittent IV boluses versus continuous infusions.

Calcium channel blocker strategy

MICU patients assigned to Team Red will receive an intravenous (IV) calcium channel blocker strategy to manage AF with RVR

Group Type: EXPERIMENTAL

Calcium channel blocker strategy

Intervention Type: DRUG

Clinicians within the intervention groups will be free to use whatever dosing amount and frequency of their assigned medication class that they deem as medically appropriate, including the decision to use intermittent IV boluses versus continuous infusions.

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

Group Type: ACTIVE_COMPARATOR

Physician preference strategy

Intervention Type: DRUG

This strategy allows for "usual care," with providers selecting their preferred rate-control agent. IV beta-blockers available through the inpatient pharmacy include metoprolol or esmolol, and IV calcium channel blockers include diltiazem and verapamil.

Interventions

Beta-blocker strategy

Clinicians within the intervention groups will be free to use whatever dosing amount and frequency of their assigned medication class that they deem as medically appropriate, including the decision to use intermittent IV boluses versus continuous infusions.

Intervention Type: DRUG

Calcium channel blocker strategy

Clinicians within the intervention groups will be free to use whatever dosing amount and frequency of their assigned medication class that they deem as medically appropriate, including the decision to use intermittent IV boluses versus continuous infusions.

Intervention Type: DRUG

Physician preference strategy

This strategy allows for "usual care," with providers selecting their preferred rate-control agent. IV beta-blockers available through the inpatient pharmacy include metoprolol or esmolol, and IV calcium channel blockers include diltiazem and verapamil.

Intervention Type: DRUG

Other Intervention Names

metoprolol or esmolol; diltiazem and verapamil

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan Walkey, MD

Role: STUDY_DIRECTOR

Pulmonary Center Boston Medical Center

Locations

Boston Medical Center MICU

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-39217

Identifier Type: -

Identifier Source: org_study_id