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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation with rapid ventricular response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 1, 2009
Last Updated
July 25, 2011
Sponsor
Seoul National University Hospital
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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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