Amsterdam UMC
Amsterdam, Netherlands
Location status: Recruiting
NCT Number: NCT07459478
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amsterdam, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tilt table testing
only biofeedback, no tilt table testing
Time frame: From enrollment to the end of the follow-up at 12 months.
The rate of syncope recurrence
Time frame: Enrollment to 1 year after tilt-table test
Time till the first syncope after tilt-table testing
Time frame: Enrollment till 1 year after tilt table testing
Amount of near-syncopal events
Time frame: Enrollment till 1 year after testing
Amount of made healthcare costs
Time frame: 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
Contact information is provided by the study sponsor or research team.
Elvira S Amaral Gomes
CONTACT
Thomas T Boel, MD
CONTACT
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
Acronym: TiltSYNC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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