Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial



Status:Recruiting
Conditions:Atrial Fibrillation, Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/22/2018
Start Date:June 1, 2018
End Date:March 2020
Contact:Tammy T Nguyen, PharmD, BCPS
Email:Tammy.Nguyen@vcuhealth.org
Phone:8046630969

Use our guide to learn which trials are right for you!

The primary objective of this study is to compare the incidence of rate control (defined as:
HR <110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration
between oral immediate release diltiazem and intravenous continuous infusion diltiazem.

Atrial fibrillation (AF), a supraventricular tachyarrhythmia, is the primary diagnosis for
over 467,000 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 4,060 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 beats/min)
was as effective as strict control (HR <80 beats/min) 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 beats/min 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 0.25 mg/kg is usually administered to obtain a heart rate of <
110 beats/min or a decrease of at least 20% in the ventricular rate. If this does not work
then a second bolus of 0.35mg/kg is administered. Once rate control of <110 beats/min 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.

Inclusion Criteria:

- >/= 18 years old

- Atrial fibrillation or flutter on electrocardiogram

- Heart rate >110 beats/min

- Systolic blood pressure >/= 90 mmHg

Exclusion Criteria:

- Limited English proficiency (LEP)

- Pregnant

- Prisoners

- Wolff Parkinson White syndrome

- Administration of electrical or chemical cardioversion before screening

- Administration of other antiarrhythmics for acute heart rate control (excluding
adenosine)

- History of allergy or idiosyncratic reaction to diltiazem

- Unable to take oral medications

- Heart rate <60 beats/min
We found this trial at
1
site
Richmond, Virginia 23298
(804) 828-0100
Phone: 804-663-0969
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials