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Rate Control in Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655303
First Posted: August 1, 2012
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tehran University of Medical Sciences
  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 Intervention Phase
Rapid Ventricular Response Atrial Fibrillation Drug: Propranolol Drug: Metoprolol Drug: Verapamil Drug: Diltiazem Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Drugs adverse effects [ Time Frame: 2 hours ]
    Drugs adverse effects seen in patients in 2 hours after per oral medication administration

  • Unstability in hemodynamic [ Time Frame: 2 hours ]
    Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain)


Enrollment: 90
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metoprolol Per Oral
50 mg Metoprolol
Drug: Metoprolol
Other Name: Metoral
Experimental: Verapamil
40 mg Verapamil Per Oral
Drug: Verapamil
Experimental: Propranolol
40 mg Propranolol Per Oral
Drug: Propranolol
Other Name: Inderal
Experimental: Diltiazem
60 mg Diltiazem Per Oral
Drug: Diltiazem

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655303


Locations
Iran, Islamic Republic of
Rasoul-e-Akram Hospital
Tehran, Iran, Islamic Republic of, 14436151
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01655303     History of Changes
Other Study ID Numbers: 16057
First Submitted: July 30, 2012
First Posted: August 1, 2012
Last Update Posted: August 1, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Propranolol
Metoprolol
Verapamil
Diltiazem
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Calcium Channel Blockers
Membrane Transport Modulators