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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01655303
Other study ID # 16057
Secondary ID
Status Completed
Phase Phase 4
First received July 30, 2012
Last updated July 30, 2012
Start date February 2011
Est. completion date December 2011

Study information

Verified date July 2012
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Propranolol

Metoprolol

Verapamil

Diltiazem


Locations

Country Name City State
Iran, Islamic Republic of Rasoul-e-Akram Hospital Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate less than 100 per minute Ventricular rate less than 100 per minute after 1 hour of per oral medication administration In 1 hour No
Secondary Drugs adverse effects Drugs adverse effects seen in patients in 2 hours after per oral medication administration 2 hours Yes
Secondary Unstability in hemodynamic Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain) 2 hours Yes