Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

This study is currently recruiting participants.

Verified July 2011 by Seoul National University Hospital

First Received on February 1, 2009. Last Updated on July 25, 2011 History of Changes

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00834925

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 IV

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

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

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
Verapamil
Calcium Channel Blockers

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 09, 2012