A Phase 4 interventional study of Diltiazem Oral Product and Diltiazem Injectable Product in Atrial Fibrillation and Flutter, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Virginia Commonwealth University · Phase 4, Interventional, and Treatment
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 19 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diltiazem immediate release 60mg orally once (Diltiazem oral product)
Drug: Diltiazem Oral Product
Diltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Drug: Diltiazem Injectable Product
Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
Diltiazem Continuous Infusion Titrated
Heart Rate Control
Number of participant achieving heart rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem
Time frame: 2 hrs
Adverse Event Rate
Number of participants with heart rate or blood pressure adverse events: Heart rate \< 60 beats/min, or systolic blood pressure \<90 mmHg requiring intervention (intravenous fluid bolus, vasopressors, medication discontinuation)
Time frame: 4 hrs
Participant Specific Variables Associated With Heart Rate Control in Each Treatment Arm
These variables include: Age, sex, race, weight, history of atrial fibrillation or flutter, history of hypertension, history of congestive heart failure, prior medication therapy, mean initial HR, duration of atrial fibrillation or flutter episode (\<48 hrs or \>48 hrs), mean initial diltiazem dose (mg/kg)
Time frame: 4 hrs
| Milestone | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem |
|---|---|---|
| Started | 9 | 10 |
| Completed | 8 | 6 |
| Not completed | 1 | 4 |
| Withdrew: Treatment no longer indicated | 1 | 2 |
| Withdrew: Physician decision | 0 | 2 |
Number of participant achieving heart rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem
| Participants | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem |
|---|---|---|
| Heart Rate Control | 8 | 4 |
Number of participants with heart rate or blood pressure adverse events: Heart rate \< 60 beats/min, or systolic blood pressure \<90 mmHg requiring intervention (intravenous fluid bolus, vasopressors, medication discontinuation)
| Participants | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem |
|---|---|---|
| Adverse Event Rate | 1 | 0 |
These variables include: Age, sex, race, weight, history of atrial fibrillation or flutter, history of hypertension, history of congestive heart failure, prior medication therapy, mean initial HR, duration of atrial fibrillation or flutter episode (\<48 hrs or \>48 hrs), mean initial diltiazem dose (mg/kg)
Results for this outcome have not been posted.
Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Immediate Release Diltiazem | — | 1/8 (12.5%) | — |
| Continuous Infusion IV Diltiazem | — | 0/6 (0%) | — |
| Event | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem |
|---|---|---|
| HypotensionCardiac disorders | 1/8 | 0/6 |
| BraydcardiaCardiac disorders | 1/8 | 0/6 |
| Age, Continuous(Years) | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem | Total |
|---|---|---|---|
| Mean | 61.7 ± 11.6 | 58.3 ± 9.9 | 59.9 ± 10.6 |
| Sex: Female, Male(Participants) | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 5 | 4 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 10 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 6 | 10 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Oral Immediate Release Diltiazem | Continuous Infusion IV Diltiazem | Total |
|---|---|---|---|
| United States | 9 | 10 | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Mar 2021, 33 months.
Results were first posted in Mar 2023, 1 year 11 months after primary completion.
Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's 33 months is below that.
Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diltiazem
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