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NCT Number: NCT07459478

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Syncope recurrence rate

    Time frame: From enrollment to the end of the follow-up at 12 months.

    The rate of syncope recurrence

  2. Time till first syncope

    Time frame: Enrollment to 1 year after tilt-table test

    Time till the first syncope after tilt-table testing

Secondary outcomes

  1. Near-syncope recurrence rate

    Time frame: Enrollment till 1 year after tilt table testing

    Amount of near-syncopal events

  2. Health Technology Assesment

    Time frame: Enrollment till 1 year after testing

    Amount of made healthcare costs

  3. Quality of life

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Elvira S Amaral Gomes

CONTACT

[email protected]

Thomas T Boel, MD

CONTACT

[email protected]

31 20 5669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial

Acronym: TiltSYNC

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 9, 2026
Registry last updated
Mar 11, 2026

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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