Investigating the effect of ivabradine on controlling the ventricular response of atrial fibrillation
Design
In this study, G*Power software is used to calculate the sample size. The variable investigated in this study is a quantitative variable and the measurements will be done before the start of the treatment and one month after the start of the treatment. 30 patients will be examined. In this research, there is no need for randomization and blinding.
Settings and conduct
The present study will be conducted on patients with stable and permanent AF referred to Imam Khomeini Educational-treatment Hospital, Ahvaz.
Participants/Inclusion and exclusion criteria
- In order to enter this study, patients must have a resting heart rate of more than 100 beats per minute, while confirming that they are suffering from permanent or persistent AF in the initial examinations, and the previous medications have no effect on improving their conditions.
-Patients with conditions: lack of consent to start or continue treatment, people under 18 years of age, pregnant women, women who breastfeed their children, patients with acute liver and kidney failure, unstable vital signs, Patients with uncontrolled blood pressure and patients who show acute side effects during treatment will be excluded from the study.
Intervention groups
In this research, an attempt will be made to investigate the effect of one month's use of ivabradine at a dose of 5 mg twice a day in controlling the ventricular response of patients with permanent and persistent AF.
Main outcome variables
Heart beat; Ventricular response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240207060933N1
Registration date:2024-02-14, 1402/11/25
Registration timing:prospective
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
Registrant information
Name
Yasaman Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 0000
Email address
yasaman199271@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Ivabradine Drug on Controlling the Ventricular Response in Atrial Fibrillation
Public title
Investigating the Effect of Ivabradine Drug on Controlling the Ventricular Response in Atrial Fibrillation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with permanent or persistent AF
Heart rate greater than 100 beats per minute at rest.
Exclusion criteria:
Age less than 18 years
Pregnant women
Women who breastfeed their children
Patients with acute liver and kidney failure
Lack of consent to start or continue the treatment process
Patients with uncontrolled blood pressure
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-02-07, 1402/11/18
Ethics committee reference number
IR.AJUMS.REC.1402.626
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
Ventricular Response
Timepoint
one month
Method of measurement
ECG Holter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One month's use of ivabradine at a dose of 5 mg twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Babak Payami
Street address
Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 2222 1144
Email
hemam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zaker kish
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Babak Payami
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 6721
Email
Payami-b@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Babak Payami
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 6721
Email
Payami-b@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Yasaman Asadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Golestan Blv, Zip Code: 61357- 15794
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Fax
Email
Yasaman199271@yahoo.com
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