Syncope. Syncope and collapse
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: Participants in this group will receive oral midodrine along with standardized non-pharmacological management.Drug: Midodrine, an alpha-adrenerg
Sponsors
Yazd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Primary school children aged 6 to 12 years with a history of recurrent syncope attacks Normal EEG findings Normal ECG and echocardiography findings (no arrhythmia, cardiomyopathy, or structural heart problems) Positive head-up tilt table test (HUTT) results
Exclusion criteria
Exclusion criteria: Pre-existing cardiac arrhythmias, cardiomyopathy, or structural heart abnormalities identified via ECG or echocardiography Severe comorbidities such as uncontrolled hypertension, chronic kidney disease, or severe asthma Concurrent use of medications affecting syncope or blood pressure (e.g., beta-blockers, fludrocortisone, diuretics) Known hypersensitivity or allergy to midodrine Inability to comply with the study protocol, including monthly follow-ups or adherence to non-pharmacological measures Presence of neurological disorders or conditions affecting consciousness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of syncope attacks over the six-month follow-up period. Timepoint: Baseline (pre-intervention); one month, three months, and six months post-treatment. Method of measurement: Monitored through parental reports and verified during monthly clinic visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of any drug-related adverse effects, including supine hypertension, palpitations, headache, piloerection, and urinary retention. Timepoint: Weekly (via parental reports) and monthly during clinic visits, over a six-month period. Method of measurement: Assessed through a standardized questionnaire and parental reports. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHadi Zare-Zardini
Yazd University of Medical Sciences
Outcome results
None listed