Study of the therapeutic effects of Atomoxetine in comparison with placebo on reducing the incidence of symptoms in patients with recurrent vasovagal syncope;
Study of therapeutic effects of Atomoxtein in reducing the incidence of symptoms in patients with recurrent vasovagal syncope
Design
The study is a double-blind randomized, placebo-controlled study
Settings and conduct
The men randomly divided into two groups: 1) standard treatment (necessary training) and medication; 2) standard treatment and placebo groups (randomized).
Group 1 is treated with Atomoxetine (starting with 10 mg and increasing the dose to 40 mg by symptom and tolerance), and the control group only receives the necessary routine recommendations and training to prevent the symptoms which are given to vasovagal patients (with placebo)
Then follow up will be done during 3 months, general judgment of vital signs and ECG, the degree of tolerance of orthostatic status, blood pressure reduction of pre-syncope symptoms and syncope), and the results were analyzed by SPSS program. Takes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who come to the heart of Tehran with a syncope or pre-syncope complaint and who have undergone tilt test or clinical diagnosis of vasovagal syncope and experienced at least 4 attacks per year.
Exit criteria:
Age under 10 and over 70 years
History of Uncontrolled Blood Pressure
History of Structural heart Disease
History of epilepsy
Closure angle glaucoma
Use of monoamine oxidase inhibitors (MAOIs)
Concomitant use of paroxetine or fluoxetine
Intervention groups
Intervention group: Atomoxetine starting with a dose of 10 mg and delivering a dose of 40 mg during one month
Control group: Receive placebo with the above command
Main outcome variables
The recurrence rate of the syncope during the three-month follow up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180125038507N1
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:1
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Masih Tajdini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9640
Email address
mtajdini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the therapeutic effects of Atomoxetine in comparison with placebo on reducing the incidence of symptoms in patients with recurrent vasovagal syncope;
Public title
Study of therapeutic effects of Atomoxtein in reducing the symptoms of patients with recurrent vasovagal syncope
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who come to the heart of Tehran with a syncope or pre-syncope complaint and who have undergone tilt test or clinical diagnosis of vasopressa syncope and experienced at least 4 attacks per year.
Exclusion criteria:
Age under 10 and over 70 years old
History of uncontrolled blood pressure,
history of structural heart diseas
history of epilepsy,
history of closed angle glaucoma,
use of monoamine oxidase inhibitors (MAOIs),
concomitant administration of paroxetine and fluoxetine
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized and divided into two groups based on permutation blocks and they fall into one of the drug and placebo groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are randomized and divided into two groups based on permutation blocks
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Tehran University of Medical Sciences
Street address
North kargar street, Tehran heart center
City
Tehran
Province
Tehran
Postal code
1411713138
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.295
Health conditions studied
1
Description of health condition studied
Syncope
ICD-10 code
R55
ICD-10 code description
Syncope and collapse
Primary outcomes
1
Description
Evaluation of recurrence of syncope during three months of the follow up
Timepoint
Clinic visit on 0,7,30,60,90
Method of measurement
Based on history and physical Exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Atomoxetine 10 mg may be taken orally at daily intake and increased by 5 mg per week and at the end of the month will be given at a dose of 40 mg.
Category
Treatment - Drugs
2
Description
Control group: Placebo pills are administered orally daily for a period of 4 weeks with the same order of intervention which is produced by pharmacy department of Tehran University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Masih Tajdini
Street address
North kargar stret
City
tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
drmasih84@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masih Tajdini
Street address
North kargar street
City
tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
drmasih84@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masih Tajdini
Position
Assistant professor of cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
North kargar street
City
tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
drmasih84@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Bozorgi
Position
Assistant professor of cardiology
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
north kargar street
City
tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9731
Email
saeedtofighi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Tofighi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
North kargar street
City
Tehran
Province
Tehran
Postal code
1411319839
Phone
+98 21 8802 9600
Email
Saeedtofighi69@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be published
When the data will become available and for how long
2019
To whom data/document is available
All
Under which criteria data/document could be used
All
From where data/document is obtainable
Dr Masih Tajdini
What processes are involved for a request to access data/document