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Clinical trial

Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial

ID
Name
HM20009559
Description
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 arms
Trial start
2018-06-01
Estimated PCD
2021-03-21
Trial end
2021-03-21
Status
Completed
Phase
Early phase I
Treatment
Diltiazem Oral Product
Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is \<60 kg)
Arms:
Oral Immediate Release Diltiazem
Diltiazem Injectable Product
Diltiazem Continuous Infusion Titrated
Arms:
Continuous Infusion IV Diltiazem
Size
19
Primary endpoint
Heart Rate Control
2 hrs
Eligibility criteria
Inclusion Criteria: * \>/= 18 years old * Atrial fibrillation or flutter on electrocardiogram * Heart rate \>110 beats/min * Systolic blood pressure \>/= 90 mmHg Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-03-01

1 organization

1 product

1 indication

Organization
Virginia Commonwealth University
Product
Diltiazem
Indication
Atrial Fibrillation