Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07459478

Multicenter Randomized Controlled Trial to Assess the Benefit of Tilt Table Testing in Patients with Vasovagal Syncope, TiltSYNC-trial

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-03-11

238

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the benefit of adding tilt table testing to biofeedback and standard care in patients with certain or highly likely vasovagal syncope. This condition causes fainting due to a sudden drop in heart rate and blood pressure. The trial aims to compare outcomes between patients receiving biofeedback with tilt table testing and those receiving biofeedback without tilt table testing, as current evidence on the value of tilt table testing is lacking. Participants are randomly assigned to one of two groups: one group receives biofeedback and standard care along with tilt table testing, while the other group receives biofeedback and standard care without tilt table testing. Tilt table testing is used as a diagnostic tool to provoke syncope under controlled conditions. The study explores whether this provocation improves patient management and outcomes. During the study, participants will be monitored for syncope recurrence, time until the first syncope event, near-syncope episodes, health technology assessments, and quality of life over a 12-month follow-up period after enrollment. Researchers will collect data on these outcomes to evaluate the impact of tilt table testing on the condition. The study is scheduled to begin in October 2025 and continue until March 2028.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Certain or highly likely vasovagal syncope after guideline-based syncope evaluation
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Diagnosed with reflex syncope other than vasovagal syncope
  • Contraindication for tilt table testing as decided by the physician
  • Presence of a learning disability
  • Experiencing pre-syncope without complete loss of consciousness
  • Unwillingness to provide informed consent
  • Previously diagnosed patients referred for specific treatment options

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day (tilt table testing or no tilt table testing)

Participants receive biofeedback and standard of care, with or without tilt table testing depending on their assigned group.

1 baseline visit (in-person)

Follow-up

Duration - 12 months

Participants are followed for 12 months after enrollment to monitor syncope recurrence, near-syncope events, and quality of life.

Periodic follow-up visits throughout the year

Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

T

Thomas T Boel, MD

E

Elvira S Amaral Gomes

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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