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

Last updated: August 27, 2021
Sponsor: University of Campania "Luigi Vanvitelli"
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Dizzy/fainting Spells

Cataplexy

Treatment

N/A

Clinical Study ID

NCT05029323
22062020
  • Ages > 14
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • No informed consent
  • PM/ICD device recipients

Study Design

Total Participants: 500
Study Start date:
January 07, 2020
Estimated Completion Date:
January 07, 2023

Study 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.

Connect with a study center

  • University of Campania "Luigi Vanvitelli"

    Naples,
    Italy

    Active - Recruiting

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