Assesment of the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: biofeedback and standard of care with tilt table testing, no tilt table testing.
- Who it may be relevant to
- Registry conditions: Vasovagal Syncope (VVS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
Overview
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 test biofeedback and standard of care with tilt table testing
tilt table testing - Diagnostic test no tilt table testing
only biofeedback, no tilt table testing
Primary outcome measures
- Syncope recurrence rate [Time frame: From enrollment to the end of the follow-up at 12 months.]
- Time till first syncope [Time frame: Enrollment to 1 year after tilt-table test]
Secondary outcome measures (3)
- Near-syncope recurrence rate [Time frame: Enrollment till 1 year after tilt table testing]
- Health Technology Assesment [Time frame: Enrollment till 1 year after testing]
- Quality of life [Time frame: Enrollment till 1 year after testing]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT07459478 · NL-009238