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

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

Study Overview

• Status: Recruiting
• Conditions: Vasovagal Syncope (VVS)
• Intervention / Treatment: Diagnostic test: biofeedback and standard of care with tilt table testing; Diagnostic test: no tilt table testing

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 Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas T Boel, MD; Phone Number: 31 20 5669111; Email: t.t.boel@amsterdamumc.nl
• Study Contact Backup: Name: Elvira S Amaral Gomes; Email: e.s.amaralgomes@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Thomas T Boel; Phone Number: 31 20 5669111; Email: t.t.boel@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biofeedback and standard of care with tilt table testing	Diagnostic test: biofeedback and standard of care with tilt table testing; tilt table testing
Active Comparator: biofeedback and standard of care without tilt table testing	Diagnostic test: no tilt table testing; only biofeedback, no tilt table testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near-syncope recurrence rate	Amount of near-syncopal events	Enrollment till 1 year after tilt table testing
Health Technology Assesment	Amount of made healthcare costs	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	Enrollment till 1 year after testing

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Frederik J de Lange, MD, PhD, AmsterdamUMC

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Biofeedback; Syncope; Therapeutic; Tilt table testing; Suspected vasovagal syncope
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: NL-009238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No