Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

July 25, 2011 updated by: Seoul National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

  • age<18
  • systolic blood pressure<90mmHg
  • no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate of rate control
Time Frame: in 30 minutes
in 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ANTICIPATED)

August 1, 2011

Study Registration Dates

First Submitted

February 1, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (ESTIMATE)

February 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diltiazem Af

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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