Vasovagal Syncope (VVS)
Conditions
Keywords
Suspected vasovagal syncope, Tilt table testing, Syncope, Therapeutic, Biofeedback
Brief summary
multicenter prospective randomized controlled comparison of biofeedback with tilt table testing (investigational management strategy) vs biofeedback without tilt table testing (reference management strategy) in patients with certain/highly likely vasovagal syncope
Detailed description
Syncope is very common and has a broad differential diagnosis. The diagnosis reflex syncope, orthostatic hypotension, POTS or psychogenic syncope rely mainly on the initial syncope evaluation that consists of history taking, physical examination (including supine and standing blood pressure measurement) and ECG (class I, Level C). Besides the initial evaluation for the diagnosis also reassurance, explanation and education with biofeedback on life style measures is an important part of standard care and treatment of these patients (class 1, level B). In the current guidelines on syncope, provocation on tilt table testing should be considered in patients with suspected reflex syncope (Class IIb, Level B). For vasovagal syncope, which is a form of reflex syncope, tilt table testing has become a widely accepted tool in the work up and treatment, however evidence for this is lacking so far. In current medical practice there is a true equipoise for the use of provocation on tilt table in these patients. A randomized controlled trial to compare the standard of care without tilt table test versus standard of care with tilt table test in patients with certain/highly likely vasovagal syncope has never been done so far.
Interventions
DIAGNOSTIC_TESTbiofeedback and standard of care with tilt table testing
tilt table testing
DIAGNOSTIC_TESTno tilt table testing
only biofeedback, no tilt table testing
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients \>18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation
Exclusion criteria
* Those aged \<18 years * Any patient diagnosed with another form of reflex syncope other than vasovagal syn-cope * Contraindication for tilt table testing at the discretion of the responsible physician * Those with a learning disability * Those presenting with pre-syncope and not with complete loss of consciousness * Those who are unwilling to provide informed consent * Those already diagnosed prior to evaluation who are referred for specific treatment op-tions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Syncope recurrence rate | From enrollment to the end of the follow-up at 12 months. | The rate of syncope recurrence |
| Time till first syncope | Enrollment to 1 year after tilt-table test | Time till the first syncope after tilt-table testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Near-syncope recurrence rate | Enrollment till 1 year after tilt table testing | Amount of near-syncopal events |
| Health Technology Assesment | Enrollment till 1 year after testing | Amount of made healthcare costs |
| Quality of life | Enrollment till 1 year after testing | Quality of life using: SF-12: Short-form 12: higher scores indicate a better quality of life. Scores are transformed using standardized transformation. Mean score 50; population score mean / mean score 40 or 60 equals a 1SD deviation from the mean population score. SDF: Syncope daily function: higher scores are better daily functioning Minimal score 16, maximum score 51 |
Countries
Netherlands
Contacts
CONTACTThomas T Boel, MD
CONTACTElvira S Amaral Gomes
PRINCIPAL_INVESTIGATORFrederik J de Lange, MD, PhD
AmsterdamUMC
Outcome results
None listed