Assesment of the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial

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.

• biofeedback and standard of care with tilt table testing (Diagnostic test): tilt table testing
• no tilt table testing (Diagnostic test): only biofeedback, no tilt table testing

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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

• Frederik J de Lange, MD, PhD, Principal investigator, AmsterdamUMC