- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00834925
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
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 Contact
- Name: Kyuseok Kim
- Phone Number: +82-31-787-3049
- Email: dremkks@snubh.org
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- Sang Hoon Na, MD, PhD
- Phone Number: +82-2-2072-3047
- Email: nasanghoon@gmail.com
-
-
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
|
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.
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Diltiazem
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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