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Atrial Fibrillation and FlutterPhase 4OVID RAFNCT03472495

Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial

A Phase 4 study testing Diltiazem Oral Product and Diltiazem Injectable Product in people with Atrial Fibrillation and Flutter, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation and Flutter
What is being tested?
Diltiazem Oral Product and Diltiazem Injectable Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
1 Jun 2018to 21 Mar 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • >/= 18 years old
  • Atrial fibrillation or flutter on electrocardiogram
  • Heart rate >110 beats/min
  • Systolic blood pressure >/= 90 mmHg

Who cannot join

  • 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)
Show all 9Show fewer
  • History of allergy or idiosyncratic reaction to diltiazem
  • Unable to take oral medications
  • Heart rate <60 beats/min

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Diltiazem Oral Product, Diltiazem Injectable Product
Keywords
Diltiazem, Atrial Fibrillation, Atrial Flutter, Emergency Medicine
Medical subject headings
Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diltiazem Oral ProductDrug

    Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is <60 kg)

  • Diltiazem Injectable ProductDrug

    Diltiazem Continuous Infusion Titrated

Study groups in NCT03472495
Study groupRoleWhat they receive
Oral Immediate Release DiltiazemActive comparatorDiltiazem immediate release 60mg orally once (Diltiazem oral product)
Receives: Drug: Diltiazem Oral Product
Continuous Infusion IV DiltiazemActive comparatorDiltiazem 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)
Receives: Drug: Diltiazem Injectable Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 hrs

Secondary outcomes (1)
  1. 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)

    Measured: 4 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2018
  2. Study start1 Jun 2018
  3. Primary completion21 Mar 2021
  4. Study completion21 Mar 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03472495
Sponsor's protocol ID
HM20009559
Acronym
OVID RAF
Status last verified
Feb 2023
First submitted
23 Feb 2018
Last updated
1 Mar 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diltiazem Oral Product and Diltiazem Injectable Product in people with Atrial Fibrillation and Flutter, run by Virginia Commonwealth 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 1 Mar 2023. 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?

Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Heart Rate Control (time frame: 2 hrs). 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 1 Mar 2023.

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