The purpose of the study is to compare the positivity rate associated with a novel simplified Tilt-Table (TT) test protocol versus the conventional TT protocol
All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) will be randomized to "conventional" HUTT protocol or "fast" HUTT protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; a provocation phase of further 10 min after 300 micrograms NTG sublingual spray. The novel simplified "fast" HUTT protocol has been designed to provide non inferior positivity rates as compared with the conventional protocol in the selected population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
500
Fast HUTT protocol stabilization phase of 5 min in the supine position; passive phase of 10 min at a tilt angle of 60 degrees; provocation phase of further 10 min after 300 micrograms NTG sublingual spray.
Conventional HUTT protocol stabilization phase of 5 min in the supine position; passive phase of 20 min at a tilt angle of 60 degrees; provocation phase of further 15 min after 300 micrograms NTG sublingual spray.
University of Campania "Luigi Vanvitelli"
Naples, Italy
RECRUITINGHUTT positivity rate during passive phase
The study endpoint is the number of patients who experienced syncope during the passive phase of HUTT.
Time frame: through study completion, an average of 1 year
HUTT positivity rate during active phase
The study endpoint is the number of patients who experienced syncope during the active phase of HUTT.
Time frame: through study completion, an average of 1 year
The type of HUTT-induced syncope during passive phase
The secondary study endpoint is the number of patients with cardioinhibitory HUTT-syncope during the passive phase of HUTT.
Time frame: through study completion, an average of 1 year
The type of HUTT-induced syncope during active phase
The secondary study endpoint is the number of patients with cardioinhibitory HUTT-syncope during the active phase of HUTT.
Time frame: through study completion, an average of 1 year
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