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Status unknownNCT04141553Updated Oct 28, 2019

Bolus vs IVP (Intravenous Push) Diltiazem for Atrial Fibrillation or Flutter

A Phase 4 interventional study of Diltiazem Injection in Atrial Fibrillation, Atrial Flutter and Rapid Ventricular Response, sponsored by Mercy Health Muskegon. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-28.

Sponsored by Mercy Health Muskegon · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The administration of intravenous non-dihydropyridine calcium channel blockers such as diltiazem for patients presenting in atrial fibrillation with rapid ventricular response, without evidence of pre-excitation, are recommended first-line therapies by the American Heart Association.1 Hypotension warrants careful consideration in the treatment of atrial fibrillation with a rapid ventricular response. Hemodynamic stability is a continuum, however, and rate control is often vital, particularly in patients who are refractory to electrical cardioversion [or who have underlying conditions such that tachycardia is not well tolerated]. Diltiazem has been utilized in dosing such as 2.5 mg/min in those with decreased blood pressure and atrial fibrillation with elevated ventricular rate.2 Lim et al. in 2002 demonstrated the effectiveness of a slow infusion of diltiazem 2.5 mg/min to a maximum of 50 mg to control rate in supraventricular tachycardia.

The study of the slow infusion of diltiazem has been limited to supraventricular tachycardia. No literature exists evaluating the efficacy of such a gradual infusion in atrial fibrillation or atrial flutter, rhythms affecting 2.7 million to 6.1 million Americans.1,3 It can be reasoned that a gradual infusion of diltiazem will minimize side effects, predominantly hypotension, and perhaps even demonstrate efficacy in alleviating hypotension due to decreased stroke volume from excessive tachycardia. The proposed benefits of an infusion, as compared to a bolus, would allow for the termination of an infusion as soon as rate control is achieved thus limiting the potential for hypotension. With current evidence-based literature validating the superiority of non-dihydropyridine calcium channel blockers and questions surrounding present recommendations of weight based intravenous dosing, the authors suggest an inquiry into the utility of a gradual infusion of diltiazem for initial rate control in patients presenting with atrial fibrillation or flutter with or without hypotension related to excessive tachycardia.

This is a prospective, randomized, double blind investigation to compare the effectiveness of standard IV (intravenous) push diltiazem at 0.25 mg/kg (to a maximum of 25 mg) over 2 minutes, with a potential repeat dose of 0.35 mg/kg if the initial dose is not effective versus a slow infusion of 50 mg of IV diltiazem diluted in 50 mL of 0.9% normal saline (NS) administered over 20 minutes. The investigators anticipate the data to be collected over the course of 2-3 years. These methods of diltiazem administration are already accepted practices at our institution and are consistent with current approved product labeling and professional judgment based upon clinical experience, and therefore the investigators do not foresee any additional risk to patients enrolled in our proposed study. In either treatment group, should hypotension or other clinical evidence of poor systemic perfusion, no additional IV diltiazem, or additional administration of a diltiazem infusion will be administered. The primary outcome measured will be the efficacy of treatment as defined by the obtainment of a heart rate of \<110 beats/minute within 30 minutes of drug administration. Secondary outcomes evaluated will include the need for additional medications to achieve rate control including the need for repeat diltiazem bolus at 0.35 mg/kg, electrical cardioversion, admission, allergic reactions, and side effects including, but not limited to, systolic blood pressure less than 90 mmHg or bradycardia with heart rate less than 60 bpm.

02

Conditions studied

  • Atrial Fibrillation
  • Atrial Flutter
  • Rapid Ventricular Response
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 300 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Mercy Health Muskegon as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Be 18 years and older,
  • Present with atrial fibrillation or atrial flutter with a rapid ventricular response
  • Have a 12-lead ECG (electrocardiogram) showing atrial fibrillation or atrial flutter with a rapid ventricular rate greater than 120 beats per minute.
  • Able to provide consent for self, or have a legally authorized representative available to provide consent by proxy.
  • Have a cardiac history not inclusive of the diagnoses listed under exclusion criteria.

Exclusion criteria

Exclusion Criteria:

  • Altered mental status as a direct result of hemodynamic instability
  • Heart rate >220 beats per minute
  • 2nd or 3rd degree atrioventricular block
  • QRS (time for ventricular repolarization) >110 milliseconds
  • Temperature >38 Celsius
  • Acute STEMI (ST-Elevation Myocardial Infarction)
  • Pulmonary edema
  • Unstable angina
  • Allergy to diltiazem
  • Pregnancy
  • Breastfeeding
  • History of pre-excitation syndrome
  • Decompensated heart failure
  • Incarcerated persons
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Diltiazem IV push

    In the standard IV push group, diltiazem will be administered at a dose of 0.25 mg/kg, to a max dose of 25 mg, over 2 minutes. At time 0, these participants will also receive 30 mg of immediate release oral diltiazem. After 15 minutes, if adequate rate control of \<110 BPM has not been achieved, an additional dose 0.35 mg/kg to a max dose of 35 mg will be administered. In order to maintain the blind, the control group will also receive 50 mL of 0.9% NS IV over 20 minutes.

    Drug: Diltiazem Injection

  • Active comparator
    Diltiazem IV Slow Infusion

    In the slow infusion group, 50 mg of diltiazem will be diluted in 50 mL of 0.9% NS and infused over 20 minutes. Similar the other group, these participants will also receive 30 mg of immediate release oral diltiazem. In order to maintain the blind, this slow infusion group will receive the equivalent volume of IV 0.9% NS over 2 minutes as a placebo.

    Drug: Diltiazem Injection

Interventions

  • Randomization to one of to active comparator groups

    Also known as: diltiazem immediate release oral tablet, 0.9% saline

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What researchers measure

Primary outcomes

  1. Resolution of arrhythmia

    Efficacy of treatment as defined by the achievement of a heart rate of \<110 beats/minute

    Time frame: within 30 minutes of drug administration

Secondary outcomes

  1. Use of additional medications to achieve rate control

    Percentage of patients who require medications other than diltiazem to achieve rate control.

    Time frame: within 30 minutes of diltiazem administration

  2. Frequency of cardioversion

    Incidence of electrical cardioversion to achieve rate control

    Time frame: within 30 minutes of diltiazem administration

  3. Frequency of hospital admission

    Percentage of enrolled patients who require hospital admission to achieve and maintain rate control

    Time frame: within 24 hours of study related treatment in the Emergency Department.

  4. Identification of adverse events.

    Characterization and frequency of adverse events

    Time frame: at the time of diltiazem administration and and immediately following the medication

  5. Occurrence of allergic reactions

    Evaluate occurrence of allergic reactions

    Time frame: at the time of diltiazem administration and and immediately following the medication

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Data will not be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04141553
Lead sponsor
Mercy Health Muskegon
Responsible party
Joseph Betcher, MD (Principal Investigator, Mercy Health Muskegon) — Principal investigator
First posted
Oct 28, 2019
Start date
Dec 1, 2019 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Oct 28, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. 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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