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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional HUTT | Active Comparator | 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. |
|
| Fast HUTT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast HUTT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The type of HUTT-induced syncope during active phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Russo, MD PhD | Contact | +390817062355 | vincenzo.russo@unicampania.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Russo, MD PhD | University of Campania Luigi Vanvitelli | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campania "Luigi Vanvitelli" | Recruiting | Naples | Italy |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Conventional HUTT | 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. |
|
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 |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |