Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- HUTT positivity rate during passive phase
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients with unexplained syncope at initial evaluation and indication to perform HUTT
Exclusion Criteria
- •No informed consent
- •PM/ICD device recipients
Arms & Interventions
Conventional HUTT
All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) randomized to "conventional" 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; aprovocation phase of further 10 min after 300 micrograms NTG sublingual spray.
Intervention: Conventional HUTT (Diagnostic Test)
Fast HUTT
All patients with unexplained syncope at initial evaluation with indication to perform a Head up tilt test (HUTT) randomized to "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.
Intervention: Fast HUTT (Diagnostic Test)
Outcomes
Primary Outcomes
HUTT positivity rate during passive phase
Time Frame: through study completion, an average of 1 year
The study endpoint is the number of patients who experienced syncope during the passive phase of HUTT.
HUTT positivity rate during active phase
Time Frame: through study completion, an average of 1 year
The study endpoint is the number of patients who experienced syncope during the active phase of HUTT.
Secondary Outcomes
- The type of HUTT-induced syncope during passive phase(through study completion, an average of 1 year)
- The type of HUTT-induced syncope during active phase(through study completion, an average of 1 year)
Investigators
Vincenzo Russo
Principal Investigator
University of Campania "Luigi Vanvitelli"