A Phase 4 interventional study of Oral and Intravenous drug in Atrial Fibrillation and Atrial Flutter, sponsored by Spectrum Health - Lakeland. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Spectrum Health - Lakeland · Phase 4, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 444 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Spectrum Health - Lakeland is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg. 15 minutes following Diltiazem Infusion administer oral Diltiazem 60mg IR Tablet, do not give if BP\<100
Drug: Oral
these patients will receive traditional treatments at provider discretion. To be included in teh study their initial heart rate must also be over 125, and 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.
Drug: Intravenous drug
Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg
Also known as: these patients will receive oral and intravenous diltiazem
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.
Admission Rate
This will compare rates of patients admitted between the protocol group and patients treated traditionally
Time frame: 1 days
Treatment Success at 3 Hours
This will compare the total number of patients who in 3 hours from first medicine administration achieved heart rate less than 110 between the protocol and traditional treatment group
Time frame: 3 hours
Rate of Hypotension
rates of patients experiencing systolic blood pressure less than 90
Time frame: 1 day
| Milestone | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response |
|---|---|---|
| Started | 177 | 267 |
| Completed | 172 | 249 |
| Not completed | 5 | 18 |
This will compare rates of patients admitted between the protocol group and patients treated traditionally
| Participants | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response |
|---|---|---|
| Admission Rate | 98 | 188 |
This will compare the total number of patients who in 3 hours from first medicine administration achieved heart rate less than 110 between the protocol and traditional treatment group
| Participants | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response |
|---|---|---|
| Treatment Success at 3 Hours | 150 | 192 |
rates of patients experiencing systolic blood pressure less than 90
| Participants | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response |
|---|---|---|
| Rate of Hypotension | 7 | 17 |
Collected over Adverse event data were collected for 24 hours following emergency room admittance.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diltiazem With Oral and Intravenous Treatment | 0/177 (0%) | 0/177 (0%) | 7/177 (4%) |
| Traditional Atrial Fibrillation With Rapid Ventricular Response | 1/267 (0.4%) | 0/267 (0%) | 17/267 (6.4%) |
| Event | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response |
|---|---|---|
| HypotensionVascular disorders | 7/177 | 17/267 |
| Age, Continuous(years) | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response | Total |
|---|---|---|---|
| Mean | 69.1 ± 13.3 | 71 ± 12.7 | 70.05 ± 13 |
| Sex: Female, Male(Participants) | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response | Total |
|---|---|---|---|
| Female | 102 | 138 | 240 |
| Male | 75 | 129 | 204 |
| Race (NIH/OMB)(Participants) | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 20 | 37 | 57 |
| White | 157 | 230 | 387 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Diltiazem With Oral and Intravenous Treatment | Traditional Atrial Fibrillation With Rapid Ventricular Response | Total |
|---|---|---|---|
| United States | 177 | 267 | 444 |
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Spectrum Health - Lakeland