NCT05029323

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Syncope
• Syncope;Heat Induced

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fast HUTT	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.
DIAGNOSTIC_TEST	Conventional HUTT	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.

Timeline

• Start date: 2020-01-07
• Primary completion: 2023-01-07
• Completion: 2023-01-07
• First posted: 2021-08-31
• Last updated: 2021-08-31

Locations

1 site across 1 country: Italy