Evaluating the clinical efficacy of adding Ivabradine to the standard treatment in reducing the frequency of premature atrial complexes (PAC) in ECG holter comparing to the standard treatment , in patients with symptomatic frequent premature atrial complexes (PAC)
Determining the clinical efficacy of Ivabradine in reducing the frequency of PAC in ECG holter comparing to the standard treatment , in patients with symptomatic frequent PACs
Design
The study is a randomized clinical trial which will be single blinded and single center. Randomization will be done by the method of permuted block with randomized blocks of double, quadruple and sextet. For complying the allocation concealment, a web based method will be used.
Settings and conduct
This study will be done at Tehran Heart center, where the selected patients will be referred to electrophysiology clinic to enter study after being aware of all aspects of it. They use the selected treatment depending to the group they are joined, and at the 12th day of treatment, will undergo a 24-hourECG holter. Then the holter will be reviewed and the patients will be visited for the second time.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Ages between 18-75 years
- PAC frequency in ECG holter between 5-10 % (average of 8% total heart beats).
- The ability to understand and sign the letter of satisfaction
Exclusion criteria:
- History of using Ivabradine during last 2 months
- Cardiovascular disorders
- Congenital long QT or QT>500 msec at the beginning of study
- using drugs with major interactions with Ivabradine
- Pregnant or lactating patients
- Advanced liver disease
- AF rhythm.
Intervention groups
Patients referring to Tehran Heart Center clinic which have PAC frequency of 5-10% (about 8%) in 24-hour ECG holter. Two groups of 50 patients will participate in this study, that one of them will receive Ivabradine plus standard treatment for PAC (Metoprolol 25 mg po BD), while the other group will only receive the standard treatment.
Main outcome variables
Frequency of PAC in 24 hours ECG holter
Symptoms of patients with symptomatic frequent PACs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058519N1
Registration date:2023-08-16, 1402/05/25
Registration timing:registered_while_recruiting
Last update:2023-08-16, 1402/05/25
Update count:0
Registration date
2023-08-16, 1402/05/25
Registrant information
Name
Layla Nematipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2205 5676
Email address
l.nematipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the clinical efficacy of adding Ivabradine to the standard treatment in reducing the frequency of premature atrial complexes (PAC) in ECG holter comparing to the standard treatment , in patients with symptomatic frequent premature atrial complexes (PAC)
Public title
Evaluating the efficacy of Ivabradine in reducing the frequency of PAC , in patients with symptomatic frequent PACs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient in ages between 18-75 years.
PAC frequency in ECG holter be between 5-10 % (average of 8%).
Patients who have the ability to understand and sign the letter of satisfaction.
Exclusion criteria:
Patient have the history of using Ivabradine during last 2 months.
Patients having cardiovascular disorders.
Patients having congenital long QT or QT>500 msec at the beginning of study.
using drugs with reducing heart rate effect, which have major interactions with Ivabradine.
Patients whom are pregnant or lactating or tending to become pregnant.
Patients suffering from advanced liver disease (class C of Child-Pugh score).
Patient having the history of using Ivabradine, whom has had discontinued Ivabradine because of adverse effects.
Patient having AF rhythm.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The study is a randomized clinical trial which will be single center. Randomization will be done by the method of permuted block with randomized blocks of double, quadruple and sextet. For complying the allocation concealment, a web based method will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Intersection of Qods Ave
City
Tehran
Province
Tehran
Postal code
1416633591
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.232
Health conditions studied
1
Description of health condition studied
Frequent premature atrial complex (PAC)
ICD-10 code
I49.1
ICD-10 code description
Atrial premature depolarization
Primary outcomes
1
Description
Frequency of PAC in 24 hours ECG holter
Timepoint
To understand the effect of Ivabradine on reducing the frequency of PAC, further holter will be done on 12th day of study for 24 hours.
Method of measurement
ECG holter
Secondary outcomes
1
Description
Rate of reduction in PAC frequency in ECG holter
Timepoint
To understand the effect of Ivabradine on reducing the frequency of PAC, further holter will be done on 12th day of study for 24 hours.
Method of measurement
24 hours ECG holter
2
Description
Symptoms of patients with symptomatic frequent PACs
Timepoint
To understand the effect of Ivabradine on reducing the frequency of PAC, further holter will be done on 12th day of study for 24 hours.
Method of measurement
24 hours ECG holter
Intervention groups
1
Description
Intervention group: Patients in intervention group use Ivabradine 5mg twice daily for 2 weeks. All of the patients in both groups, receive metoprolol 25mg BID as the standard treatment.
Category
Treatment - Drugs
2
Description
Control group: In control group patients only use the standard treatment as metoprolol 25mg BID for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Mr Dr Farzad Masoudkabir
Street address
Tehran heart center, corner of the Jalaal-Al-Ahmad expressway, North Kaargar Ave.
City
Tehran
Province
Tehran
Postal code
13138-14117
Phone
+98 21 8802 9600
Email
thc@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran heart center
Full name of responsible person
Dr Farzad Masoudkabir
Street address
Tehran heart center, corner of the Jalaal-Al-Ahmad expressway, North Kaargar Ave.
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
thc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran heart center
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
Tehran heart center
Full name of responsible person
Dr Layla Nematipour
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Henter, Corner of Jalaal-Al-Ahmad Expressway, North Kaargar Ave.
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
l.nematipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Layla Nematipour
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Henter, Corner of Jalaal-Al-Ahmad Expressway, North Kaargar Ave.
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
l.nematipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Layla Nematipour
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Henter, Corner of Jalaal-Al-Ahmad Expressway, North Kaargar Ave.
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
l.nematipour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information is 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