Low Dose of Diltiazem for Rate Control of Atrial Fibrilla... | NCT00834925

Studies
Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

NCT00834925

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 26, 2011Estimated

Enrollment

380Estimated

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

low dose diltiazem

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2011Estimated

First Submitted Date

Feb 1, 2009

First Submission Date that Met QC Criteria

Feb 2, 2009

First Posted Date

Feb 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2011

Last Update Posted Date

Jul 26, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

380Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard dose diltiazem	No Intervention
low dose diltiazem	Experimental		Drug: low dose diltiazem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low dose diltiazem	Drug	Low dose diltiazem: 0.15mg/kg over 2 minutes Standard dose diltiazem: 0.25mg/kg over 2 minutes	low dose diltiazem

Measure	Description	Time Frame
Success rate of rate control		in 30 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

age<18
systolic blood pressure<90mmHg
no consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyuseok Kim	Contact	+82-31-787-3049		dremkks@snubh.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004110	Diltiazem

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided