Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00834925
First received: February 1, 2009
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: low dose diltiazem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Success rate of rate control [ Time Frame: in 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

  • age<18
  • systolic blood pressure<90mmHg
  • no consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834925

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

Locations
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

No publications provided

Responsible Party: Min Seung Chun, Mitsubishi-Tanabe Coperation Group
ClinicalTrials.gov Identifier: NCT00834925     History of Changes
Other Study ID Numbers: Diltiazem Af
Study First Received: February 1, 2009
Last Updated: July 25, 2011
Health Authority: Korea: Food and Drug Administration

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
Diltiazem
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014