No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
140 (estimated)
Sponsor
Istituto Auxologico Italiano · Other
Who this trial is looking for
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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), in reducing syncope recurrences in patients affected by hypotensive syncope during one year of follow-up.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 du…
Inclusion Criteria:
* 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 Criteria:
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