Back to resultsValidation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
Primary Purpose
Syncope, Syncope;Heat Induced
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fast HUTT
Conventional HUTT
Sponsored by
About this trial
This is an interventional diagnostic trial for Syncope
Eligibility Criteria
Inclusion Criteria:
- All patients with unexplained syncope at initial evaluation and indication to perform HUTT
Exclusion Criteria:
- No informed consent
- PM/ICD device recipients
Sites / Locations
- University of Campania "Luigi Vanvitelli"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional HUTT
Fast HUTT
Arm 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.
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.
Outcomes
Primary Outcome Measures
HUTT positivity rate during passive phase
The study endpoint is the number of patients who experienced syncope during the passive phase of HUTT.
HUTT positivity rate during active phase
The study endpoint is the number of patients who experienced syncope during the active phase of HUTT.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05029323
First Posted
July 27, 2021
Last Updated
August 27, 2021
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT05029323
Brief Title
Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
Official Title
Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
January 7, 2023 (Anticipated)
Study Completion Date
January 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Syncope;Heat Induced
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional HUTT
Arm Type
Active Comparator
Arm 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.
Arm Title
Fast HUTT
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fast HUTT
Intervention Description
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
Intervention Name(s)
Conventional HUTT
Intervention Description
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.
Primary Outcome Measure Information:
Title
HUTT positivity rate during passive phase
Description
The study endpoint is the number of patients who experienced syncope during the passive phase of HUTT.
Time Frame
through study completion, an average of 1 year
Title
HUTT positivity rate during active phase
Description
The study endpoint is the number of patients who experienced syncope during the active phase of HUTT.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The type of HUTT-induced syncope during passive phase
Description
The secondary study endpoint is the number of patients with cardioinhibitory HUTT-syncope during the passive phase of HUTT.
Time Frame
through study completion, an average of 1 year
Title
The type of HUTT-induced syncope during active phase
Description
The secondary study endpoint is the number of patients with cardioinhibitory HUTT-syncope during the active phase of HUTT.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with unexplained syncope at initial evaluation and indication to perform HUTT
Exclusion Criteria:
No informed consent
PM/ICD device recipients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Russo, MD PhD
Phone
+390817062355
Email
vincenzo.russo@unicampania.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Russo, MD PhD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Study Chair
Facility Information:
Facility Name
University of Campania "Luigi Vanvitelli"
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Russo
Email
vincenzo.russo@unicampania.it
First Name & Middle Initial & Last Name & Degree
Vincenzo Russo
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of a Novel Simplified Head up Tilt Test (HUTT) Protocol Versus the Conventional Protocol
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