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

NCT04234477 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: H-39217
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

beta-blocker; calcium channel blocker; rapid ventricular rate (RVR)

Outcome Measures

Primary Outcomes (1)

• Adherence to assigned class of medication

  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.

  6 months

Secondary Outcomes (2)

• Average number of cases of AF with RVR occurring monthly

  6 months

• Percentage of patients who received an IV rate control agent that had AF with RVR

  6 months

Study Arms (3)

Beta-blocker strategy

EXPERIMENTAL

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

Drug: Beta-blocker strategy

Calcium channel blocker strategy

EXPERIMENTAL

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

Drug: Calcium channel blocker strategy

Physician preference strategy

ACTIVE COMPARATOR

MICU patients assigned to Team Green will receive a physician preference strategy with usual/standard of care interventions to manage AF with RVR

Drug: Physician preference strategy

Interventions

Beta-blocker strategy 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.

Also known as: metoprolol or esmolol

Beta-blocker strategy

Calcium channel blocker strategy 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.

Also known as: diltiazem and verapamil

Calcium channel blocker strategy

Physician preference strategy 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.

Physician preference strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center MICU

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Metoprolol; esmolol; Diltiazem; Verapamil

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines

Study Officials

• Allan Walkey, MD

  Pulmonary Center Boston Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-11

Locations

US (1)