Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03472495
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-02-23
Brief Title:
Oral vs Intravenous Diltiazem for Rapid Atrial FibrillationFlutter Trial
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Oral vs Intravenous Diltiazem for Rapid Atrial FibrillationFlutter Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OVID RAF
Brief Summary:
The primary objective of this study is to compare the incidence of rate control defined as HR 110 beatsmin or conversion to sinus rhythm at 2 hours after medication administration between oral immediate release diltiazem and intravenous continuous infusion diltiazem
Detailed Description:
Atrial fibrillation AF a supraventricular tachyarrhythmia is the primary diagnosis for over 467000 hospitalizations each year Historically there have been two approaches to managing AF in the emergency department ED rate control and rhythm control
The AFFIRM trial compared rate and rhythm control in 4060 patients It found no difference in mortality with the rate control approach and less hospitalizations As a result both rhythm and rate control are options in stable patients with an AF duration of 48 hours After 48 hours rate control is preferred because of the increased risk of ischemic stroke The subsequent RACE II trial established that lenient heart rate control HR 110 beatsmin was as effective as strict control HR 80 beatsmin in preventing cardiovascular events and required less outpatient visits to achieve the goal HR As a result of both the AFFIRM and RACE II trials a rate control approach with a goal HR of 80-110 beatsmin is the management plan for a majority of patients who present to the ED in AF According to the American Heart Association 2014 guidelines the initial acute emergent management of atrial fibrillation and flutter AFF are similar and there are a number of medications used for rate control including beta blockers and non-dihydropyridine calcium channel blockers
Diltiazem a non-dihydropyridine calcium channel blocker is often the medication of choice in the management of AFF due to its ability to be given as an intravenous IV push continuous infusion and oral PO immediate release or extended release tablet In the ED a loading dose of IV diltiazem 025 mgkg is usually administered to obtain a heart rate of 110 beatsmin or a decrease of at least 20 in the ventricular rate If this does not work then a second bolus of 035mgkg is administered Once rate control of 110 beatsmin or a 20 decrease in ventricular rate is obtained physicians typically chose between oral immediate release diltiazem tablet or IV continuous infusion diltiazem to maintain heart rate control Both options allow for dose changes in the short term The oral immediate release diltiazem tablet has a fast onset of action of 30-60 minutes and is dosed every 6 hours Intravenous continuous infusion diltiazem has a variable onset of action with a titration frequency of every 15-30 minutes The use of oral diltiazem allows for possible placement on a monitored general floor bed whereas an intravenous drip requires placement to step down or intensive level of care This impacts bed status and length of stay in the emergency department Both oral and intravenous diltiazem are used clinically however no prospective studies exist comparing the two strategies Retrospective data suggests that both forms are equal in their ability to control heart rate
The AFFIRM trial compared rate and rhythm control in 4060 patients It found no difference in mortality with the rate control approach and less hospitalizations As a result both rhythm and rate control are options in stable patients with an AF duration of 48 hours After 48 hours rate control is preferred because of the increased risk of ischemic stroke The subsequent RACE II trial established that lenient heart rate control HR 110 beatsmin was as effective as strict control HR 80 beatsmin in preventing cardiovascular events and required less outpatient visits to achieve the goal HR As a result of both the AFFIRM and RACE II trials a rate control approach with a goal HR of 80-110 beatsmin is the management plan for a majority of patients who present to the ED in AF According to the American Heart Association 2014 guidelines the initial acute emergent management of atrial fibrillation and flutter AFF are similar and there are a number of medications used for rate control including beta blockers and non-dihydropyridine calcium channel blockers
Diltiazem a non-dihydropyridine calcium channel blocker is often the medication of choice in the management of AFF due to its ability to be given as an intravenous IV push continuous infusion and oral PO immediate release or extended release tablet In the ED a loading dose of IV diltiazem 025 mgkg is usually administered to obtain a heart rate of 110 beatsmin or a decrease of at least 20 in the ventricular rate If this does not work then a second bolus of 035mgkg is administered Once rate control of 110 beatsmin or a 20 decrease in ventricular rate is obtained physicians typically chose between oral immediate release diltiazem tablet or IV continuous infusion diltiazem to maintain heart rate control Both options allow for dose changes in the short term The oral immediate release diltiazem tablet has a fast onset of action of 30-60 minutes and is dosed every 6 hours Intravenous continuous infusion diltiazem has a variable onset of action with a titration frequency of every 15-30 minutes The use of oral diltiazem allows for possible placement on a monitored general floor bed whereas an intravenous drip requires placement to step down or intensive level of care This impacts bed status and length of stay in the emergency department Both oral and intravenous diltiazem are used clinically however no prospective studies exist comparing the two strategies Retrospective data suggests that both forms are equal in their ability to control heart rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None