Study of therapeutic effects of Atomoxtein in reducing the symptoms of patients with recurrent vasovagal syncope
Phase 3
Completed
- Conditions
- Syncope.Syncope and collapse
- Registration Number
- IRCT20180125038507N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients who come to the Tehran Heart Center with a complaint of syncope or pre-syncope with the clinical diagnosis of vasovagal syncope or have undergone tilt test, if needed, and experienced at least 3 syncopal episodes in the past 3 months.
Exclusion Criteria
Age under 10 or over 70 years old
History of uncontrolled blood pressure
History of structural heart disease
History of epilepsy
History of closed angle glaucoma
History of diabetes mellitus
History of coronary artery disease
Ejection fraction < 50%
Use of monoamine oxidase inhibitors (MAOIs)
Use of selective serotonin reuptake inhibitors (SSRIs)
Use of anticonvulsants
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of (pre-)syncopal episodes. Timepoint: Follow-up visit at month 1 and 3. Method of measurement: Based on history and physical exam.
- Secondary Outcome Measures
Name Time Method Anxiety. Timepoint: Follow-up visit on month 3. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.;Depression. Timepoint: Follow-up visit on month 3. Method of measurement: Hospital Anxiety and Depression Scale Questionnaire.;Physical quality of life. Timepoint: Follow-up visit on month 3. Method of measurement: 36-Item Short Form Survey Questionnaire.;Mental quality of life. Timepoint: Follow-up visit on month 3. Method of measurement: 36-Item Short Form Survey Questionnaire.