Vasovagal Syncope (VVS)TiltSYNCNCT07459478
Assesment of the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
A study testing no tilt table testing in people with Vasovagal Syncope (VVS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasovagal Syncope (VVS)
- What is being tested?
- no tilt table testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients >18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elvira S Amaral Gomes contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Thomas T Boel, 31 20 5669111, t.t.boel@amsterdamumc.nl
About this study
Official title: Multicenter RCT to Assess 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
Read the 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.
- Conditions
- Vasovagal Syncope (VVS)
- Being tested
- biofeedback and standard of care with tilt table testing, no tilt table testing
- Keywords
- Suspected vasovagal syncope, Tilt table testing, Syncope, Therapeutic, Biofeedback
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback and standard of care with tilt table testingDiagnostic test
tilt table testing
no tilt table testingDiagnostic test
only biofeedback, no tilt table testing
| Study group | Role | What they receive |
|---|---|---|
| biofeedback and standard of care with tilt table testing | Experimental | Not described Receives: Diagnostic Test: biofeedback and standard of care with tilt table testing |
| biofeedback and standard of care without tilt table testing | Active comparator | Not described Receives: Diagnostic Test: no tilt table testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syncope recurrence rate
The rate of syncope recurrence
Measured: 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
Measured: Enrollment to 1 year after tilt-table test
Secondary outcomes (3)
Near-syncope recurrence rate
Amount of near-syncopal events
Measured: Enrollment till 1 year after tilt table testing
Health Technology Assesment
Amount of made healthcare costs
Measured: 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
Measured: Enrollment till 1 year after testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start30 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasovagal Syncope (VVS)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik de Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frederik J de Lange, MD, PhD, Principal investigator, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459478
- Sponsor's protocol ID
- NL-009238
- Acronym
- TiltSYNC
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
- ClinicalTrials.gov ID
- NCT07459478
- Acronym / sponsor ID
- TiltSYNC / NL-009238
- Conditions
- Vasovagal Syncope (VVS)
- Keywords
- Suspected vasovagal syncope, Tilt table testing, Syncope, Therapeutic, Biofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback and standard of care with tilt table testing | Experimental | Diagnostic Test: biofeedback and standard of care with tilt table testing |
| biofeedback and standard of care without tilt table testing | Active comparator | Diagnostic Test: no tilt table testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients >18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biofeedback and standard of care with tilt table testingtilt table testing | Diagnostic test | biofeedback and standard of care with tilt table testing |
| no tilt table testingonly biofeedback, no tilt table testing | Diagnostic test | biofeedback and standard of care without tilt table testing |
Primary outcome
Syncope recurrence rate
Time frame: From enrollment to the end of the follow-up at 12 months.
The rate of syncope recurrence
Time till first syncope
Time frame: Enrollment to 1 year after tilt-table test
Time till the first syncope after tilt-table testing
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Vasovagal Syncope (VVS)
Active, not recruitingObservational study
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RecruitingObservational study
POLish Registry of CArdioneuroablation and CArdioneuromodulation
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
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A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elvira S Amaral Gomes contact
Frederik J de Lange, MD, PhD principal investigator
AmsterdamUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no tilt table testing in people with Vasovagal Syncope (VVS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas T Boel, MD (31 20 5669111, t.t.boel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syncope recurrence rate (time frame: From enrollment to the end of the follow-up at 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.