Low Dose of Diltiazem for Rate Control of Atrial Fibrillation
This study is currently recruiting participants.
Verified July 2011 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00834925
First received: February 1, 2009
Last updated: July 25, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: low dose diltiazem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Drug Information available for:
Verapamil hydrochloride
Diltiazem hydrochloride
Diltiazem
Diltiazem malate
U.S. FDA Resources
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Success rate of rate control [ Time Frame: in 30 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 380 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- atrial fibrillation with rapid ventricular response in emergency room
Exclusion Criteria:
- age<18
- systolic blood pressure<90mmHg
- no consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834925
Contacts
| Contact: Kyuseok Kim | +82-31-787-3049 | dremkks@snubh.org |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Sang Hoon Na, MD, PhD +82-2-2072-3047 nasanghoon@gmail.com | |
Sponsors and Collaborators
Seoul National University Hospital
More Information
No publications provided
| Responsible Party: | Min Seung Chun, Mitsubishi-Tanabe Coperation Group |
| ClinicalTrials.gov Identifier: | NCT00834925 History of Changes |
| Other Study ID Numbers: | Diltiazem Af |
| Study First Received: | February 1, 2009 |
| Last Updated: | July 25, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
atrial fibrillation with rapid ventricular response |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Diltiazem Verapamil Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on May 19, 2013