Tilt-table provocation for adults with vasovagal syncope
Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
This trial will test whether adding tilt-table provocation to biofeedback and standard care helps adults with confirmed or highly likely vasovagal syncope avoid future fainting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07459478 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized controlled comparison of two management strategies for adults judged to have certain or highly likely vasovagal syncope after guideline-based evaluation. One group receives biofeedback plus standard care with tilt-table provocation, and the other group receives biofeedback with standard care without tilt-table provocation. Patients are randomized to one of the two approaches and followed for clinical outcomes related to syncope recurrence and symptom burden. The trial addresses a current clinical equipoise because tilt-table testing is widely used but lacks robust randomized evidence for benefit.
Who should consider this trial
Good fit: Adults (age >18) judged to have certain or highly likely vasovagal syncope after standard diagnostic evaluation, who can provide informed consent and have no contraindication to tilt-table testing, are eligible.
Not a fit: Patients under 18, those with other forms of reflex syncope, pre-syncope only, learning disabilities, contraindications to tilt-table testing, or those already diagnosed and referred for specific treatments are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding tilt-table provocation could reduce recurrent fainting and help tailor treatment for adults with vasovagal syncope.
How similar studies have performed: Tilt-table testing is commonly used in practice but randomized controlled evidence comparing provocation versus no provocation is lacking, and no definitive RCTs have established clear benefit.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Frederik J de Lange, MD, PhD — AmsterdamUMC
- Study coordinator: Thomas T Boel, MD
- Email: t.t.boel@amsterdamumc.nl
- Phone: 31 20 5669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.