Assessment of the Mechanism of Non-cardiac Syncope

Syncope Clinical Trial

— 2STEPS  

Official title:

Assessment of the Mechanism of Non-cardiac Syncope by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) and Tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728255
• Other study ID #: 09C337
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Michele Brignole, MD
• Phone: +393204391422
• Email: m.brignole[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy.

Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table

Description:

Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Indeed, the choice of appropriate therapy and its efficacy are largely determined by the mechanism of syncope rather than its aetiology or clinical presentation. The identified mechanism of syncope should be carefully assessed and assigned either to hypotensive or bradycardic phenotype, which will determine the choice of therapy (counteracting hypotension or counteracting bradycardia).

Several tests have been developed to identify the mechanism of non-cardiac syncope. The great number of tests, most of them being time-consuming, is one of the barriers for widespread utilization in the busy clinical practice. They are expensive and often not fully reimbursed by the health services.

Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB). SCAFB consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table

The study hypothesis is that these two investigations, performed in sequence, can identify the mechanism of syncope in most of the patients in a quick and easy-to-perform way and at relatively low costs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 275
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe recurrent non-cardiac syncope referred for assessment of the mechanism of syncope. Non-cardiac syncope is diagnosed when the clinical features are consistent with reflex syncope and orthostatic hypotension, and cardiac syncope is ruled out .

Exclusion Criteria:

1. Non-syncopal causes of real or apparent loss of consciousness that may be incorrectly diagnosed as syncope (eg, unexplained falls, epilepsy, psychogenic pseudosyncope and other rare causes)

2. Established or suspected cardiac syncope in complying with the criteria of the European Society of Cardiology (ESC) syncope guidelines (1). Specifically, these were the patients with: (i) suspected cardiac arrhythmic syncope [inadequate sinus bradycardia (<50 b.p.m.) or sinoatrial block, second-degree Mobitz I atrioventricular block, second-degree Mobitz II or third-degree atrioventricular block, paroxysmal tachyarrhythmia or ventricular tachycardia, bundle branch block]; (ii) severe structural heart disease and/or significant ECG abnormalities, as defined in Table 2 of those guidelines (1).

3. Classical orthostatic hypotension diagnosed at the initial evaluation by Active Standing test

4. Constitutional or drug-induced persistent hypotension already diagnosed at the initial evaluation by office BP measurement or previous historical features

5. Non-severe forms of non-cardiac syncope, i.e., patients with rare and mild episodes occurring in low-risk situations. In these patients the investigation of the underlying mechanism of syncope is not necessary and treatment strategies are mainly based on education on preventive measures, lifestyle modification, and reassurance regarding the benign nature of the condition.

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Syncope
• Syncope, Vasovagal

Intervention

Diagnostic Test:
• ABPM plys SCAFB
24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM) and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table

Locations

Country	Name	City	State
France	University of marseille Aix en Provence	Marseille
Italy	University of Florence	Florence
Italy	ospdali del Tigullio	Lavagna
Italy	IRCCS Istituto Auxologico Italiano	Milan	MI
Italy	Università della Campania Vamvitelli	Naples
Netherlands	AMC Universisty of Amsterdam	Amsterdam
Spain	University of Barcelona Vall d'Ebron	Barcelona
Sweden	Karolinska Institut	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  Spain,  Sweden, 

References & Publications (2)

Brignole M, Rivasi G. New insights in diagnostics and therapies in syncope: a novel approach to non-cardiac syncope. Heart. 2021 Jun;107(11):864-873. doi: 10.1136/heartjnl-2020-318261. Epub 2021 Jan 18. Erratum In: Heart. 2021 Nov;107(22):e13. — View Citation

Rivasi G, Groppelli A, Brignole M, Soranna D, Zambon A, Bilo G, Pengo M, Sharad B, Hamrefors V, Rafanelli M, Testa GD, Rice C, Kenny RA, Sutton R, Ungar A, Fedorowski A, Parati G. Association between hypotension during 24 h ambulatory blood pressure monitoring and reflex syncope: the SynABPM 1 study. Eur Heart J. 2022 Oct 11;43(38):3765-3776. doi: 10.1093/eurheartj/ehac347. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	Prevalence of hypotensive and bradycardic phenotypes	1 month
Secondary	Diagnostic yield	Diagnostic yield of ABPM and of SCAFB	1 month
Secondary	Diagnosis	Case mix of etiologic diagnoses	1 month