Rate Control in Atrial Fibrillation | RxWiki

Rate Control in Atrial Fibrillation

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Rapid Ventricular Response Atrial Fibrillation
Intervention	Drug: Propranolol Drug: Metoprolol Drug: Verapamil Drug: Diltiazem
Phase	Phase 4
Sponsor	Tehran University of Medical Sciences
Responsible Party	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier	NCT01655303
First Received	July 30, 2012
Last Updated	July 30, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	July 30, 2012
Last Updated Date	July 30, 2012
Start Date	February 2011
Estimated Primary Completion Date	December 2011
Current Primary Outcome Measures	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
Current Secondary Outcome Measures	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)

Descriptive Information[ + expand ][ + ]

Brief Title	Rate Control in Atrial Fibrillation
Official Title	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	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Condition	Rapid Ventricular Response Atrial Fibrillation
Intervention	Drug: Propranolol Other Names: InderalDrug: Metoprolol Other Names: MetoralDrug: Verapamil Drug: Diltiazem
Study Arm (s)	Experimental: Metoprolol Per Oral 50 mg Metoprolol Experimental: Verapamil 40 mg Verapamil Per Oral Experimental: Propranolol 40 mg Propranolol Per Oral Experimental: Diltiazem 60 mg Diltiazem Per Oral

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	90
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011
Eligibility Criteria	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
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01655303
Other Study ID Numbers	16057
Has Data Monitoring Committee	Not Provided
Information Provided By	Tehran University of Medical Sciences
Study Sponsor	Tehran University of Medical Sciences
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	July 2012

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