Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol

Not Applicable

• Conditions: Syncope;Heat Induced; Syncope
• Interventions: Diagnostic Test: Conventional HUTT; Diagnostic Test: Fast HUTT

• Registration Number: NCT05029323
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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 Timeline

• Study Start: 2020-01-07
• Study First Submitted: 2021-07-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-27
• Last Update Submitted: 2021-08-27
• Study First Posted: 2021-08-31
• Last Update Posted: 2021-08-31
• Primary Completion: 2023-01-07
• Study Completion: 2023-01-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients with unexplained syncope at initial evaluation and indication to perform HUTT

Exclusion Criteria

• No informed consent
• PM/ICD device recipients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional HUTT	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.
Fast HUTT	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.

Primary Outcome Measures

Name	Time	Method
HUTT positivity rate during passive phase	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	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 Outcome Measures

Name	Time	Method
The type of HUTT-induced syncope during passive phase	through study completion, an average of 1 year	The secondary study endpoint is the number of patients with cardioinhibitory HUTT-syncope during the passive phase of HUTT.
The type of HUTT-induced syncope during active phase	through study completion, an average of 1 year	The secondary study endpoint is the number of patients with cardioinhibitory HUTT-syncope during the active phase of HUTT.

Trial Locations

Locations (1)

University of Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy