Rate Control in Atrial Fibrillation (-)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01655303

First received: July 30, 2012

Last updated: NA

Last verified: July 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 30, 2012
Last Updated Date	July 30, 2012
Start Date ^ICMJE	February 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2012)	Rate less than 100 per minute [ Time Frame: In 1 hour ] [ Designated as safety issue: No ] Ventricular rate less than 100 per minute after 1 hour of per oral medication administration
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 30, 2012)	Drugs adverse effects [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ] Drugs adverse effects seen in patients in 2 hours after per oral medication administration Unstability in hemodynamic [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ] Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Rate Control in Atrial Fibrillation
Official Title ^ICMJE	Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status
Brief Summary	Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments. This study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Rapid Ventricular Response Atrial Fibrillation
Intervention ^ICMJE	Drug: Propranolol Other Name: Inderal Drug: Metoprolol Other Name: Metoral Drug: Verapamil Drug: Diltiazem
Study Arm (s)	Experimental: Metoprolol Per Oral 50 mg Metoprolol Intervention: Drug: Metoprolol Experimental: Verapamil 40 mg Verapamil Per Oral Intervention: Drug: Verapamil Experimental: Propranolol 40 mg Propranolol Per Oral Intervention: Drug: Propranolol Experimental: Diltiazem 60 mg Diltiazem Per Oral Intervention: Drug: Diltiazem
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age more than 18 years old Stability in hemodynamic Exclusion Criteria: Systolic blood pressure less than 90 mm Hg Altered mental status attributable to rapid ventricular response atrial fibrillation Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation Chest pain attributable to rapid ventricular response atrial fibrillation Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem History of asthma
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01655303
Other Study ID Numbers ^ICMJE	16057
Has Data Monitoring Committee
Responsible Party	Tehran University of Medical Sciences
Study Sponsor ^ICMJE	Tehran University of Medical Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Tehran University of Medical Sciences
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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