An interventional study of biofeedback and standard of care with tilt table testing and no tilt table testing in Vasovagal Syncope (VVS), sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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
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.
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
This study's planned enrollment of 238 is above the median of 59 across 58 interventional studies indexed under Syncope, Vasovagal.
Browse Syncope, Vasovagal studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: biofeedback and standard of care with tilt table testing
Diagnostic Test: no tilt table testing
tilt table testing
only biofeedback, no tilt table testing
Syncope recurrence rate
The rate of syncope recurrence
Time frame: From enrollment to the end of the follow-up at 12 months.
Time till first syncope
Time till the first syncope after tilt-table testing
Time frame: Enrollment to 1 year after tilt-table test
Near-syncope recurrence rate
Amount of near-syncopal events
Time frame: Enrollment till 1 year after tilt table testing
Health Technology Assesment
Amount of made healthcare costs
Time frame: Enrollment till 1 year after testing
Quality of life
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
Time frame: Enrollment till 1 year after testing
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 19 months after the start.
Of 29 interventional studies with no phase under Syncope, Vasovagal, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
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