Trial Outcomes & Findings for Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation (NCT NCT05391893)

NCT ID: NCT05391893

Last Updated: 2024-12-27

Results Overview

This will compare rates of patients admitted between the protocol group and patients treated traditionally

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 444 participants
• Primary outcome timeframe: 1 days
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	Diltiazem With Oral and Intravenous Treatment 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 Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg	Traditional Atrial Fibrillation With Rapid Ventricular Response 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. Intravenous drug: 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.
Overall Study STARTED	177	267
Overall Study COMPLETED	172	249
Overall Study NOT COMPLETED	5	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation

Baseline characteristics by cohort

Measure	Diltiazem With Oral and Intravenous Treatment n=177 Participants 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 Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg	Traditional Atrial Fibrillation With Rapid Ventricular Response n=267 Participants 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. Intravenous drug: 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.	Total n=444 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	71 years STANDARD_DEVIATION 12.7 • n=7 Participants	70.05 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	138 Participants n=7 Participants	240 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	129 Participants n=7 Participants	204 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	37 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) White	157 Participants n=5 Participants	230 Participants n=7 Participants	387 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	177 participants n=5 Participants	267 participants n=7 Participants	444 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 days

This will compare rates of patients admitted between the protocol group and patients treated traditionally

Outcome measures

Measure	Diltiazem With Oral and Intravenous Treatment n=172 Participants 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 Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg	Traditional Atrial Fibrillation With Rapid Ventricular Response n=249 Participants 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. Intravenous drug: 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	98 Participants	188 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Diltiazem With Oral and Intravenous Treatment n=177 Participants 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 Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg	Traditional Atrial Fibrillation With Rapid Ventricular Response n=267 Participants 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. Intravenous drug: 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.
Treatment Success at 3 Hours	150 Participants	192 Participants

SECONDARY outcome

Timeframe: 1 day

rates of patients experiencing systolic blood pressure less than 90

Outcome measures

Measure	Diltiazem With Oral and Intravenous Treatment n=177 Participants 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 Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg	Traditional Atrial Fibrillation With Rapid Ventricular Response n=267 Participants 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. Intravenous drug: 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.
Rate of Hypotension	7 Participants	17 Participants

Adverse Events

Diltiazem With Oral and Intravenous Treatment

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Traditional Atrial Fibrillation With Rapid Ventricular Response

Serious events: 0 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diltiazem With Oral and Intravenous Treatment n=177 participants at risk 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 Oral: Diltiazem 0.25mg/kg injection, give over 2 minutes, max dose 30mg	Traditional Atrial Fibrillation With Rapid Ventricular Response n=267 participants at risk 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. Intravenous drug: 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.
Vascular disorders Hypotension	4.0% 7/177 • Adverse event data were collected for 24 hours following emergency room admittance.	6.4% 17/267 • Adverse event data were collected for 24 hours following emergency room admittance.

Additional Information

Rachelle Pichot; Clinical Research Specialist

SpectrumLakeland

Phone: (240)389-7340

Email: rachelle.pichot@corewellhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place