Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
OVID RAF
1 other identifier
interventional
19
1 country
1
Brief Summary
The primary objective of this study is to compare the incidence of rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release diltiazem and intravenous continuous infusion diltiazem.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2018
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2021
CompletedResults Posted
Study results publicly available
March 1, 2023
CompletedMarch 1, 2023
February 1, 2023
2.8 years
February 23, 2018
February 3, 2023
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart Rate Control
Number of participant achieving heart rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release and intravenous continuous infusion diltiazem
2 hrs
Secondary Outcomes (1)
Adverse Event Rate
4 hrs
Other Outcomes (1)
Participant Specific Variables Associated With Heart Rate Control in Each Treatment Arm
4 hrs
Study Arms (2)
Oral Immediate Release Diltiazem
ACTIVE COMPARATORDiltiazem immediate release 60mg orally once (Diltiazem oral product)
Continuous Infusion IV Diltiazem
ACTIVE COMPARATORDiltiazem 2.5-5 mg/hour intravenous Titrate by 1.25 mg every 15-60 minutes. Maximum titration dose 15 mg/hour. Titration Goal of HR \<110 (Diltiazem Injectable Product)
Interventions
Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
Diltiazem Continuous Infusion Titrated
Eligibility Criteria
You may qualify if:
- \>/= 18 years old
- Atrial fibrillation or flutter on electrocardiogram
- Heart rate \>110 beats/min
- Systolic blood pressure \>/= 90 mmHg
You may not qualify if:
- Limited English proficiency (LEP)
- Pregnant
- Prisoners
- Wolff Parkinson White syndrome
- Administration of electrical or chemical cardioversion before screening
- Administration of other antiarrhythmics for acute heart rate control (excluding adenosine)
- History of allergy or idiosyncratic reaction to diltiazem
- Unable to take oral medications
- Heart rate \<60 beats/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tammy Nguyen, PharmD
- Organization
- Virginia Commonwealth University
Study Officials
- PRINCIPAL INVESTIGATOR
Tammy T Nguyen, PharmD, BCPS
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2018
First Posted
March 21, 2018
Study Start
June 1, 2018
Primary Completion
March 21, 2021
Study Completion
March 21, 2021
Last Updated
March 1, 2023
Results First Posted
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share