Comparing therapeutic effects of carvedilol and metoprolol in prevention of atrial fibrillation after coronary artery bypass surgery, double blinded study
This clinical trial compares the preventive effect of carvedilol and metoprolol on occurrence of AF after CABG surgery. Study population is going to include 150 patients (55 women, 95 men; mean age: 59±10) who are going to perform CABG surgery. Patients with no contraindication for β-blocker use are going to randomly assign into two groups of Carvedilol and Metoprolol (n=75). Treatment with β-blocker is going to start on the first postoperative day (metoprolol, 25 mg BD; carvedilol, 6.25 mg, BD) and the dosage will regulate according to the patients’ hemodynamic response. All patients will monitor 5 days after the surgery and incidence of AF and other complications will record in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111015178N2
Registration date:2014-01-03, 1392/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Rozita Jalalian
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9591
Email address
r.jalalian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing therapeutic effects of carvedilol and metoprolol in prevention of atrial fibrillation after coronary artery bypass surgery, double blinded study
Public title
therapeutic effects of Carvidelol and Metoprolol in prevention of cardiac arrhythmia after open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients indicated for CABG surgery who did not have any contraindications for beta blocker use .Exclusion criteria: chronic obstructive respiratory failure; advanced AV block; previous AF; bradycardia (HR<60); hypotension (SBP<90); ejection fraction<35%; patients who were undergoing repair or replace of heart valve along with their CABG surgery.
Age
From 21 years old to 81 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Juybar Interaction
City
Sari
Postal code
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
29/9/91
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
Atrial fibrillation
Timepoint
During the first 5 days after CABG
Method of measurement
Cardiac monitoring
Secondary outcomes
1
Description
Ventricular fibrillation
Timepoint
During the first 5 days after CABG in ICU
Method of measurement
Cardiac monitoring
Intervention groups
1
Description
A total of 150 patients 75 in each drug group, enroll in the study.Initiative dose is going to be 25 mg/BD in metoprolol group and will increase according to the patients’ hemodynamic responses.Cardiac monitoring going to performe in patients during ICU and 5 days post-ICU
Category
Prevention
2
Description
A total of 150 patients 75 in each drug group, enroll in the study.Initiative dose is going to be 6.25 daily in carvideloll group and increase according to the patients’ hemodynamic responses.Cardiac monitoring is going to performe in patients during ICU and 5 days post-ICU
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rozita Jalalian
Street address
University Building, Juybar Interaction, Imam Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Rozita Jalalian
Position
Assistant Professor of cardiology
Other areas of specialty/work
Street address
Mazandaran Heart Center, Artesh BLVD
City
Sari
Postal code
Phone
+98 15 1222 4002
Fax
Email
rozita_jalalian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rozita Jalalian
Position
Assistant Professor of cardiology
Other areas of specialty/work
Street address
Mazandaran Heart Center, Artesh BLVD
City
Sari
Postal code
Phone
+98 15 1222 4002
Fax
Email
rozita_jalalian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rozita Jalalian
Position
Assistant professor of cardiology
Other areas of specialty/work
Street address
mazandaran Heart Center, Artesh BLVD
City
Sari
Postal code
Phone
+98 15 1222 4002
Fax
Email
rozita_jalalian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)