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

NCT05391893 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EGME#03-2021
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (2)

• Admission Rate

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

  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

  3 hours

Secondary Outcomes (1)

• Rate of Hypotension

  1 day

Study Arms (2)

Diltiazem with oral and intravenous treatment

ACTIVE COMPARATOR

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

traditional atrial fibrillation with rapid ventricular response

PLACEBO COMPARATOR

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

Interventions

Oral DRUG

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

Also known as: these patients will receive oral and intravenous diltiazem

Diltiazem with oral and intravenous treatment

Intravenous drug 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.

traditional atrial fibrillation with rapid ventricular response

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Wolf-Parkinson-White syndrome
• ST Elevation Myocardial Infarction
• Pregnant
• Clinical diagnosis of Sepsis,
• Decompensated HF
• allergy to Diltiazem
• provider discretion
• clinical need for cardioversion

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Matthew Hysell

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Infusion Pumps

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Artificial Organs; Surgical Equipment

Results Point of Contact

• Title: Rachelle Pichot; Clinical Research Specialist
• Organization: SpectrumLakeland

rachelle.pichot@corewellhealth.org

(240)389-7340

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A treatment protocol using oral and IV diltiazem has been implemented. We will compare admission rates, time to heart rate control, and hypotension between the protocol group and patients receiving traditional treatments for atrial fibrillation with rapid ventricular response

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: May 26, 2022
• Study Start: June 19, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2023-10

Locations

US (1)