Phase 4
N=19
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
Atrial Fibrillation and Flutter
Bottom Line
View on ClinicalTrials.gov: NCT03472495 ↗Enrolled (actual)
19
Serious AEs
7.1%
Results posted
Mar 2023
Primary outcome: Primary: Heart Rate Control — 8; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Diltiazem Oral Product (Drug); Diltiazem Injectable Product (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Control |
8; 4 | — |
| SECONDARY Adverse Event Rate |
1; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03472495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.