Phase 4
Completed N=444
Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation
Source: ClinicalTrials.gov NCT05391893 ↗Enrolled (actual)
444
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Admission Rate — 98; 188 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Admission Rate |
98; 188 | — |
| PRIMARY Treatment Success at 3 Hours |
150; 192 | — |
| SECONDARY Rate of Hypotension |
7; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Heart rate >125
- Systolic BP>110
- Atrial Fibrillation/Flutter confirmed on ECG.
- Meets observation unit requirements (performs certain ADL's (acts of daily living)
- Age>18.
Exclusion Criteria
- Wolf-Parkinson-White syndrome
- ST Elevation Myocardial Infarction
- Pregnant
- Clinical diagnosis of Sepsis,
- Decompensated HF
- allergy to Diltiazem
- provider discretion
- clinical need for cardioversion
Data sourced from ClinicalTrials.gov (NCT05391893). 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. Informational only — not medical advice.