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Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00834925
Recruitment Status : Unknown
Verified July 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2009
Last Update Posted : July 26, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: low dose diltiazem Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2009
Primary Completion Date : August 2009
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: standard dose diltiazem
Experimental: low dose diltiazem Drug: low dose diltiazem
Low dose diltiazem: 0.15mg/kg over 2 minutes Standard dose diltiazem: 0.25mg/kg over 2 minutes

Outcome Measures

Primary Outcome Measures :
  1. Success rate of rate control [ Time Frame: in 30 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

  • age<18
  • systolic blood pressure<90mmHg
  • no consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834925

Contact: Kyuseok Kim +82-31-787-3049 dremkks@snubh.org

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang Hoon Na, MD, PhD    +82-2-2072-3047    nasanghoon@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
More Information

Responsible Party: Min Seung Chun, Mitsubishi-Tanabe Coperation Group
ClinicalTrials.gov Identifier: NCT00834925     History of Changes
Other Study ID Numbers: Diltiazem Af
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
atrial fibrillation with rapid ventricular response

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents