The purpose of this study is to evaluate the effects of Amiodarone versus Digoxin for control of heart rate in patients with rapid ventricular response atrial fibrillation(AF) referred to emergency room.
Patients who are referred to emergency rooms of Imam Hossein and Shohadaye Tajrish hospitals will be the population of this study.
The study is a blocked randomized single blind and multicentral, clinical trial.
All patients with over 110 beats per minute AF who are referred to emergency room will be included in this study. However, patients with unstable vital signs; under 18 years;without congestive heart failure; presence of hepatic or renal dysfunction; patients who are not willing to participate in this study will be excluded.
The total sample size will be 108 patients, including two groups of patients with and without history of atrial fibrillation that each groups randomly treated with Amiodarone or Digoxin.
The dose of amiodarone is 150 mg over 10 minutes followed by a 50 mg per hour slow infusion for 3 hours then 25 mg per hour for 8 hours.
Digoxin is given in an initial slow intravenous dose of 0.5 mg then if needed 0.25 mg in hours 2 and 4 of intervention.
The aim is lowering the heart rate below 100 beats per minute.
The patients will be monitored during the course of treatment and time of rate control and possible complications (such as hypotension more than 20 mmHg, heart rate less than 60 beats per minute, and other arrhythmia) will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206047449N2
Registration date:2012-11-02, 1391/08/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-02, 1391/08/12
Registrant information
Name
Majid Shojaee
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 2380
Email address
m.shojaee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti Medical University
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Amiodarone and Digoxin in controlling rapid ventricular response atrial fibrillation
Public title
The effects of Amiodarone for control of heart rate in patients with rapid ventricular response atrial fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with over 110 beats per minute Atrial Fibrillation who are referred to emergency room
Exclusion criteria:
patients with unstable vital signs who are needed electrical cardioversion; or due to underline diseases such as sepsis, anemia, bleeding, hypovolemia who are needed treatment
under 18 or over 80 years;
who haven't congestive heart failure;
who have received antiarrhythmic agents last 12 hours;
who couldn't monitoring 12 hours during the study
who are not willing to participate in this study;
presence of hepatic or renal dysfunction;
atrial fibrillation diagnosis isn't definite in ECG;
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Medical University, Medical School, Ethics Committee
Street address
Shahid Beheshti Univercity of Medical Science and Health Care, Medical School, Koodakyar Deadlock, Yemen St, Chamran Highway
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90-04-08-83
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Heart rate
Timepoint
Before the intervention,and during 12 hours of the intervention and one week after intervention
Method of measurement
Heart rate based on ECG and cardiac monitoring
Secondary outcomes
1
Description
Time to response
Timepoint
During 12 hours of intervention
Method of measurement
Heart rate based on ECG and cardiac monitoring
2
Description
Decrease in blood pressure more than 20 mmHg
Timepoint
During 12 hours of intervention
Method of measurement
Standard sphygmomanometer 2 times with 2 persons
3
Description
Decrease in heart rate less than 60 beats per minute
Timepoint
Every 1 hour during 12 hours of intervention
Method of measurement
Heart rate based on ECG and cardiac monitoring
4
Description
Occurrence of other arrhythmias
Timepoint
During 12 hours of intervention
Method of measurement
Based on ECG and cardiac monitoring
Intervention groups
1
Description
for internention:
Intravenous Amiodarone 150 mg over 10 minutes followed by a 50 mg per hour slow infusion for 3 hours then 25 mg per hour for 8 hours.
Category
Treatment - Drugs
2
Description
For control:
Digoxin is given in an initial slow intravenous dose of 0.5 mg then if needed 0.25 mg in hours 2 and 4 of intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hossein Medical & Educational Center
Full name of responsible person
Dr Majid Shojaee
Street address
Emam hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
2
Recruitment center
Name of recruitment center
Shohadaye Tajrish Medical & Educational Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Miss Tadaion
Street address
Shahid Beheshti Univercity of Medical Science and Health Care, Koodakyar Deadlock, Yemen St, Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Majid Shojaee
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
m.shojaee@sbmu.ac.ir
Web page address
www.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Majid Shojaee
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
m.shojaee@sbmu.ac.ir
Web page address
www.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Majid Shojaee
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
m.shojaee@sbmu.ac.ir
Web page address
www.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)