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

December 1, 2021 updated by: Boston University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center MICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beta-blocker strategy
MICU patients assigned to Team Blue will receive an intravenous (IV) beta-blocker strategy to manage AF with RVR
Drug: 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.
Other Names:
  • metoprolol or esmolol
Experimental: Calcium channel blocker strategy
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
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.
Other Names:
  • diltiazem and verapamil
Active Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to assigned class of medication
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average number of cases of AF with RVR occurring monthly
Time Frame: 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.
6 months
Percentage of patients who received an IV rate control agent that had AF with RVR
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Study Director: Allan Walkey, MD, Pulmonary Center Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-39217

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Beta-blocker strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe