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

NCT07459478 | Recruiting

• 1 other identifier: NL-009238
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vasovagal Syncope (VVS)

Keywords

Suspected vasovagal syncope; Tilt table testing; Syncope; Therapeutic; Biofeedback

Outcome Measures

Primary Outcomes (2)

• Syncope recurrence rate

  The rate of syncope recurrence

  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

  Enrollment to 1 year after tilt-table test

Secondary Outcomes (3)

• Near-syncope recurrence rate

  Enrollment till 1 year after tilt table testing

• Health Technology Assesment

  Enrollment till 1 year after testing

• Quality of life

  Enrollment till 1 year after testing

Study Arms (2)

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

Interventions

biofeedback and standard of care with tilt table testing DIAGNOSTIC_TEST

tilt table testing

biofeedback and standard of care with tilt table testing

no tilt table testing DIAGNOSTIC_TEST

only biofeedback, no tilt table testing

biofeedback and standard of care without tilt table testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \>18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederik J de Lange, MD, PhD

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas T Boel, MD

CONTACT

31 20 5669111; t.t.boel@amsterdamumc.nl

Elvira S Amaral Gomes

CONTACT

e.s.amaralgomes@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 9, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)