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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]
    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 ] [ 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)


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01655303     History of Changes
Other Study ID Numbers: 16057
Study First Received: July 30, 2012
Last Updated: July 30, 2012
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014