Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00834925
• Other study ID #: Diltiazem Af
• Status: Recruiting
• Phase: Phase 4
• First received: February 1, 2009
• Last updated: July 25, 2011
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: Kyuseok Kim
• Phone: +82-31-787-3049
• Email: dremkks[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: August 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

• age<18

• systolic blood pressure<90mmHg

• no consent

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• low dose diltiazem
Low dose diltiazem: 0.15mg/kg over 2 minutes Standard dose diltiazem: 0.25mg/kg over 2 minutes

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of rate control		in 30 minutes	No