Atrial FibrillationPhase 4AIRCRAFTNCT04234477
Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT)
A Phase 4 study testing Beta-blocker strategy, Calcium channel blocker strategy and Physician preference strategy in people with Atrial Fibrillation, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Beta-blocker strategy, Calcium channel blocker strategy and Physician preference strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Prisoners
- Allergies to study interventions
- Presentation consistent with acute asthma exacerbation
- Presentation consistent with acute systolic heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center MICU
Boston, Massachusetts, 02118
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Beta-blocker strategy, Calcium channel blocker strategy, Physician preference strategy
- Keywords
- beta-blocker, calcium channel blocker, rapid ventricular rate (RVR)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-blocker strategyDrug
Also called metoprolol or esmolol
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 strategyDrug
Also called diltiazem and verapamil
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 strategyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Beta-blocker strategy | Experimental | MICU patients assigned to Team Blue will receive an intravenous (IV) beta-blocker strategy to manage AF with RVR Receives: 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 Receives: 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 Receives: Drug: Physician preference strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study startDec 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: The study was not IRB approved and there were anticipated challenges in recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allan Walkey, MD, Study director, Pulmonary Center Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234477
- Sponsor's protocol ID
- H-39217
- Acronym
- AIRCRAFT
- Status last verified
- Nov 2021
- First submitted
- 16 Jan 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial Pilot Study (AIRCRAFT)
- ClinicalTrials.gov ID
- NCT04234477
- Acronym / sponsor ID
- AIRCRAFT / H-39217
- Conditions
- Atrial Fibrillation
- Keywords
- beta-blocker, calcium channel blocker, rapid ventricular rate (RVR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not IRB approved and there were anticipated challenges in recruiting participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beta-blocker strategy | Experimental | Drug: Beta-blocker strategyMICU patients assigned to Team Blue will receive an intravenous (IV) beta-blocker strategy to manage AF with RVR |
| Calcium channel blocker strategy | Experimental | Drug: Calcium channel blocker strategyMICU patients assigned to Team Red will receive an intravenous (IV) calcium channel blocker strategy to manage AF with RVR |
| Physician preference strategy | Active comparator | Drug: Physician preference strategyMICU patients assigned to Team Green will receive a physician preference strategy with usual/standard of care interventions to manage AF with RVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Prisoners
- Allergies to study interventions
- Presentation consistent with acute asthma exacerbation
- Presentation consistent with acute systolic heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-blocker strategyAlso: metoprolol or esmololClinicians 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. | Drug | Beta-blocker strategy |
| Calcium channel blocker strategyAlso: diltiazem and verapamilClinicians 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. | Drug | Calcium channel blocker strategy |
| Physician preference strategyThis 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. | Drug | Physician preference strategy |
Primary outcome
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.
2 secondary outcomes
Average number of cases of AF with RVR occurring monthly
Time frame: 6 months
Percentage of patients who received an IV rate control agent that had AF with RVR
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Walkey, MD study director
Pulmonary Center Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-blocker strategy, Calcium channel blocker strategy and Physician preference strategy in people with Atrial Fibrillation, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to assigned class of medication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.