Effect of botulinum toxin injection versus placebo injection in fat pad around the heart on the incidence of intra-hospital atrial fibrillation after open-heart surgery: a double-blind randomized clinical trial
To assess the effect of botulinum toxin injection versus placebo injection in fat pad around the heart on the incidence of intra-hospital atrial fibrillation after open-heart surgery
Design
This is a single-blind randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing open-heart surgery referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 80 years,
Indication of open-heart surgery
Exclusion criteria:
History of previous hear surgery,
Unstable angina or heart failure,
Chronic atrial fibrillation,
Aortic or mitral valvular disease,
Liver or renal or thyroid disorder,
Taking anti-arrhythmic medications
Intervention groups
Intervention group:
Injection of Botulinum Toxin Type A (manufacture by Dysport Co.) 50 U with insulin needle in fat pad around the heart single does
Control group:
Injection of serum normal saline 0.9% one U with insulin needle in fat pad around the heart single does
Main outcome variables
Primary outcome:
Intra-hospital atrial fibrillation, left ventricular ejection fraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N350
Registration date:2020-03-28, 1399/01/09
Registration timing:registered_while_recruiting
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of botulinum toxin injection versus placebo injection in fat pad around the heart on the incidence of intra-hospital atrial fibrillation after open-heart surgery: a double-blind randomized clinical trial
Public title
Effect of botulinum toxin injection versus placebo injection in fat pad around the heart on the incidence of intra-hospital atrial fibrillation after open-heart surgery: a double-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 80 years,
Indication of open-heart surgery
Exclusion criteria:
History of previous hear surgery,
Unstable angina or heart failure,
Chronic atrial fibrillation,
Aortic or mitral valvular disease,
Liver or renal or thyroid disorder,
Taking anti-arrhythmic medications
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are prescribed through injection and their shapes are perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.UMSHA.REC.1398.1062
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
Intra-hospital atrial fibrillation after open-heart surgery
Timepoint
Daily for 7 to 10 days
Method of measurement
With monitoring machine
2
Description
Left ventricular ejection fraction
Timepoint
Before open-heart surgery and one month after that
Method of measurement
Using echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Injection of Botulinum Toxin Type A (manufacture by Dysport Pharmaceutical Co.) 50 unit with insulin needle in fat pad around the heart single does
Category
Treatment - Drugs
2
Description
Control group: Injection of serum normal saline 0.9% one unit with insulin needle in fat pad around the heart single does
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Hosna Mohebi
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
gp.mohebi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hosna Mohebi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Farzad.imami@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Farzad Emami
Position
Cardiologist
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Farzad.imami@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available