CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 444 enrolled
Drug / intervention
Oral +1 moredrug
Likely dose
Diltiazem 0.25 mg/kg intravenous injection over 2 minutes, maximum dose 30 mgAI-extracted
Key inclusion· 5
  • Heart rate greater than 125 bpm
  • Systolic blood pressure greater than 110 mmHg
  • Atrial fibrillation or atrial flutter confirmed on ECG
  • Ability to perform activities of daily living (meets observation unit requirements)
Key exclusion· 7
  • Wolf-Parkinson-White syndrome
  • ST elevation myocardial infarction
  • Pregnancy
  • Clinical diagnosis of sepsis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05391893
NCT05391893Phase 4Completed

Emergency Department Atrial Fibrillation Oral Diltiazem Observation Protocol

Corewell Health South·interventional·Posted May 26, 2022·Updated Dec 27, 2024

In Brief

A Phase 4 clinical trial evaluating Oral and Intravenous drug for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 444 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMay 26, 2022
Enrollment StartJun 19, 2020
Primary CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.1 years ago

Interventions

Oraldrug

Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg

Intravenous drugdrug

these patients will receive traditional treatments at provider discretion. They must receive at least one intravenous medication for atrial fibrillation with rapid ventricular response. This will be a heterogenous group of patients receiving digoxin, amiodarone, various beta-blockers, and intravenous diltiazem without oral diltiazem.