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Rate Control in Atrial Fibrillation

Primary Purpose

Rapid Ventricular Response Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Propranolol
Metoprolol
Verapamil
Diltiazem
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rapid Ventricular Response Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rasoul-e-Akram Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Metoprolol Per Oral

Verapamil

Propranolol

Diltiazem

Arm Description

50 mg Metoprolol

40 mg Verapamil Per Oral

40 mg Propranolol Per Oral

60 mg Diltiazem Per Oral

Outcomes

Primary Outcome Measures

Rate less than 100 per minute
Ventricular rate less than 100 per minute after 1 hour of per oral medication administration

Secondary Outcome Measures

Drugs adverse effects
Drugs adverse effects seen in patients in 2 hours after per oral medication administration
Unstability in hemodynamic
Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain)

Full Information

First Posted
July 30, 2012
Last Updated
July 30, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01655303
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rapid Ventricular Response Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metoprolol Per Oral
Arm Type
Experimental
Arm Description
50 mg Metoprolol
Arm Title
Verapamil
Arm Type
Experimental
Arm Description
40 mg Verapamil Per Oral
Arm Title
Propranolol
Arm Type
Experimental
Arm Description
40 mg Propranolol Per Oral
Arm Title
Diltiazem
Arm Type
Experimental
Arm Description
60 mg Diltiazem Per Oral
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Inderal
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
Metoral
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Type
Drug
Intervention Name(s)
Diltiazem
Primary Outcome Measure Information:
Title
Rate less than 100 per minute
Description
Ventricular rate less than 100 per minute after 1 hour of per oral medication administration
Time Frame
In 1 hour
Secondary Outcome Measure Information:
Title
Drugs adverse effects
Description
Drugs adverse effects seen in patients in 2 hours after per oral medication administration
Time Frame
2 hours
Title
Unstability in hemodynamic
Description
Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain)
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rasoul-e-Akram Hospital
City
Tehran
ZIP/Postal Code
14436151
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Rate Control in Atrial Fibrillation

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