Treatment strategy in patients with recurrent vasovagal syncope
- Conditions
- Vasovagal syncopeSigns and SymptomsOther symptoms and signs involving the nervous and musculoskeletal systems
- Registration Number
- ISRCTN29932893
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
1. Clinical diagnosis of classical neurally-mediated reflex syncope, based on the medical history or non-classical diagnosis of neurally-mediated reflex syncope and a positive tilt-table test
2. Three syncope episodes in the last year
3. Recognisable prodromal symptoms
4. Aged 18 - 70 years
1. Suspected or certain heart disease and high likelihood of cardiac syncope
2. Orthostatic hypotension
3. Episodes of loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, transient ischaemic attack [TIA], intoxication, cataplexy)
4. Steal syndrome
5. Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator
6. Patient compliance doubtful
7. Patient geographically or otherwise inaccessible for follow-up
8. Patient unwilling or unable to give informed consent
9. Pregnancy
10. Life expectancy less than 1 year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Syncope recurrences during an entire treatment protocol including both physical counterpressure manoeuvres and the use of medication (midodrine)<br>2. The number of patients with recurrences during treatment with midodrine after recurrent failure of using the manoeuvres
- Secondary Outcome Measures
Name Time Method 1. Time to first recurrence syncope and presyncope<br>2. Presyncope burden<br>3. Quality of life