Low Dose of Diltiazem for Rate Control of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
low dose diltiazem
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation with rapid ventricular response
Eligibility Criteria
Inclusion Criteria:
- atrial fibrillation with rapid ventricular response in emergency room
Exclusion Criteria:
- age<18
- systolic blood pressure<90mmHg
- no consent
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard dose diltiazem
low dose diltiazem
Arm Description
Outcomes
Primary Outcome Measures
Success rate of rate control
Secondary Outcome Measures
Full Information
NCT ID
NCT00834925
First Posted
February 1, 2009
Last Updated
July 25, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00834925
Brief Title
Low Dose of Diltiazem for Rate Control of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
This study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. We will compare the standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation with rapid ventricular response in ED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation with rapid ventricular response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard dose diltiazem
Arm Type
No Intervention
Arm Title
low dose diltiazem
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
low dose diltiazem
Intervention Description
Low dose diltiazem: 0.15mg/kg over 2 minutes Standard dose diltiazem: 0.25mg/kg over 2 minutes
Primary Outcome Measure Information:
Title
Success rate of rate control
Time Frame
in 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
atrial fibrillation with rapid ventricular response in emergency room
Exclusion Criteria:
age<18
systolic blood pressure<90mmHg
no consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyuseok Kim
Phone
+82-31-787-3049
Email
dremkks@snubh.org
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Na, MD, PhD
Phone
+82-2-2072-3047
Email
nasanghoon@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Low Dose of Diltiazem for Rate Control of Atrial Fibrillation
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