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

Syncope Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029323
• Other study ID #: 22062020
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: January 7, 2023

Study information

• Verified date: August 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Vincenzo Russo, MD PhD
• Phone: +390817062355
• Email: vincenzo.russo[@]unicampania.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 7, 2023
• Est. primary completion date: January 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent
• PM/ICD device recipients

Related Conditions & MeSH terms

• Syncope

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	University of Campania "Luigi Vanvitelli"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HUTT positivity rate during passive phase	The study endpoint is the number of patients who experienced syncope during the passive phase of HUTT.	through study completion, an average of 1 year
Primary	HUTT positivity rate during active phase	The study endpoint is the number of patients who experienced syncope during the active phase of HUTT.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year