NCT00834925

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

Same day

First QC Date

February 1, 2009

Last Update Submit

July 25, 2011

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation with rapid ventricular response

Outcome Measures

Primary Outcomes (1)

  • Success rate of rate control

    in 30 minutes

Study Arms (2)

standard dose diltiazem

NO INTERVENTION

low dose diltiazem

EXPERIMENTAL
Drug: low dose diltiazem

Interventions

low dose diltiazemDRUG

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

low dose diltiazem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • atrial fibrillation with rapid ventricular response in emergency room

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Diltiazem

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Kyuseok Kim

CONTACT

+82-31-787-3049dremkks@snubh.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2009

First Posted

February 3, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

KR(1)