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

University of Campania "Luigi Vanvitelli"

Status: Unknown

Conditions: Syncope; Syncope;Heat Induced

Treatments: Diagnostic Test: Conventional HUTT; Diagnostic Test: Fast HUTT

Study type: Interventional

Funder types: Other

Identifiers

NCT05029323

22062020 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No informed consent
• PM/ICD device recipients

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Conventional HUTT

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Conventional HUTT

Fast HUTT

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Fast HUTT