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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Диагностический тест biofeedback and standard of care with tilt table testing
  tilt table testing
• Диагностический тест no tilt table testing
  only biofeedback, no tilt table testing

Первичные конечные точки

• Syncope recurrence rate [Срок оценки: From enrollment to the end of the follow-up at 12 months.]
• Time till first syncope [Срок оценки: Enrollment to 1 year after tilt-table test]

Вторичные конечные точки (3)

• Near-syncope recurrence rate [Срок оценки: Enrollment till 1 year after tilt table testing]
• Health Technology Assesment [Срок оценки: Enrollment till 1 year after testing]
• Quality of life [Срок оценки: Enrollment till 1 year after testing]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT07459478 · NL-009238

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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