Rate Control in Atrial Fibrillation

July 30, 2012 updated by: Tehran University of Medical Sciences

Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

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:

  • 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

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Metoprolol Per Oral
50 mg Metoprolol
Drug: Metoprolol
Other Names:
  • Metoral
EXPERIMENTAL: Verapamil
40 mg Verapamil Per Oral
Drug: Verapamil
EXPERIMENTAL: Propranolol
40 mg Propranolol Per Oral
Drug: Propranolol
Other Names:
  • Inderal
EXPERIMENTAL: Diltiazem
60 mg Diltiazem Per Oral
Drug: Diltiazem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate less than 100 per minute
Time Frame: In 1 hour
Ventricular rate less than 100 per minute after 1 hour of per oral medication administration
In 1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

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

February 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (ESTIMATE)

August 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16057

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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