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

NCT ID: NCT05029323

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2023-01-07

Brief Summary

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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

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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

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Syncope Syncope;Heat Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional HUTT

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.

Group Type ACTIVE_COMPARATOR

Conventional HUTT

Intervention Type DIAGNOSTIC_TEST

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.

Fast HUTT

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.

Group Type EXPERIMENTAL

Fast HUTT

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No informed consent
* PM/ICD device recipients
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Russo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Russo, MD PhD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Locations

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University of Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vincenzo Russo, MD PhD

Role: CONTACT

Phone: +390817062355

Email: [email protected]

Facility Contacts

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Vincenzo Russo

Role: primary

Vincenzo Russo

Role: backup

Other Identifiers

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22062020

Identifier Type: -

Identifier Source: org_study_id