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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05029323

Enrollment

500

Registered

2021-08-31

Start date

2020-01-07

Completion date

2023-01-07

Last updated

2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope, Syncope;Heat Induced

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.

Interventions

DIAGNOSTIC_TESTFast 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_TESTConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactVincenzo Russo, MD PhD

vincenzo.russo@unicampania.it+390817062355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026