Status:
RECRUITING
Mechanism-based Therapy of Hypotensive Syncope
Lead Sponsor:
Istituto Auxologico Italiano
Conditions:
Syncope, Vasovagal, Neurally-Mediated
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to assess the efficacy of a therapeutic strategy aimed to increase 24-hour systolic blood pressure (SBP) values, assessed by 24-hour ambulatory blood pressure monitoring (ABPM...
Detailed Description
This multicentre, prospective, observational, pragmatic study on long-term therapy of hypotensive syncope consists of two distinct twin substudies to be undergone in parallel: 1. the Drug-deprescribi...
Eligibility Criteria
Inclusion
- Patients \>18-year-old with a clinical diagnosis of severe, recurrent reflex syncope, refractory to education and life-style measures (according to the criteria of ESC guidelines) AND a diagnosis of hypotensive syncope defined as:
- Persistent or intermittent hypotension during 24-hour ABPM (ABPM1) AND/OR
- Reproduction of syncope during the Short Cardiovascular Autonomic Function Assessment (SCAFA) that consists in carotid sinus massage (CSM), 3-min active stand test, and head-up tilt test (TT) performed one after another in an uninterrupted sequence as a single procedure in a tilt table.
- 2\. Clinical indication to deprescribing of antihypertensive drugs or to prescribing of fludrocortisone therapy, as appropriate, according to the clinical practice of the investigator
Exclusion
- \-
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06513650
Start Date
May 1 2024
End Date
May 31 2026
Last Update
July 22 2024
Active Locations (9)
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1
University of marseille Aix en Provence
Marseille, France
2
IRCCS Istituto Auxologico Italiano
Milan, MI, Italy, 16149
3
IRCCS Istituto Auxologico Italiano
Milan, MI, Italy, 16149
4
University of Florence
Florence, Italy