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

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Beta-blocker strategy
Calcium channel blocker strategy
Physician preference strategy
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring beta-blocker, calcium channel blocker, rapid ventricular rate (RVR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center MICU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Beta-blocker strategy

Calcium channel blocker strategy

Physician preference strategy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Average number of cases of AF with RVR occurring monthly
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
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.

Full Information

First Posted
January 16, 2020
Last Updated
December 1, 2021
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT04234477
Brief Title
Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT)
Acronym
AIRCRAFT
Official Title
Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial Pilot Study (AIRCRAFT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study was not IRB approved and there were anticipated challenges in recruiting participants.
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
beta-blocker, calcium channel blocker, rapid ventricular rate (RVR)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beta-blocker strategy
Arm Type
Experimental
Arm Description
MICU patients assigned to Team Blue will receive an intravenous (IV) beta-blocker strategy to manage AF with RVR
Arm Title
Calcium channel blocker strategy
Arm Type
Experimental
Arm Description
MICU patients assigned to Team Red will receive an intravenous (IV) calcium channel blocker strategy to manage AF with RVR
Arm Title
Physician preference strategy
Arm Type
Active Comparator
Arm Description
MICU patients assigned to Team Green will receive a physician preference strategy with usual/standard of care interventions to manage AF with RVR
Intervention Type
Drug
Intervention Name(s)
Beta-blocker strategy
Other Intervention Name(s)
metoprolol or esmolol
Intervention Description
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
Intervention Name(s)
Calcium channel blocker strategy
Other Intervention Name(s)
diltiazem and verapamil
Intervention Description
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
Intervention Name(s)
Physician preference strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to assigned class of medication
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Average number of cases of AF with RVR occurring monthly
Description
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.
Time Frame
6 months
Title
Percentage of patients who received an IV rate control agent that had AF with RVR
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Walkey, MD
Organizational Affiliation
Pulmonary Center Boston Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Boston Medical Center MICU
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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

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