RecruitingNCT06513650

Mechanism-based Therapy of Hypotensive Syncope


Sponsor

Istituto Auxologico Italiano

Enrollment

140 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

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), in reducing syncope recurrences in patients affected by hypotensive syncope during one year of follow-up.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.
  • \. Clinical indication to deprescribing of antihypertensive drugs or to prescribing of fludrocortisone therapy, as appropriate, according to the clinical practice of the investigator

Exclusion Criteria1

  • \-

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Locations(9)

University of marseille Aix en Provence

Marseille, France

IRCCS Istituto Auxologico Italiano

Milan, MI, Italy

IRCCS Istituto Auxologico Italiano

Milan, MI, Italy

University of Florence

Florence, Italy

ospdali del Tigullio

Lavagna, Italy

Università della Campania Vamvitelli

Naples, Italy

AMC Universisty of Amsterdam

Amsterdam, Netherlands

University of Barcelona Vall d'Ebron

Barcelona, Spain

Karolinska Institut

Stockholm, Sweden

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NCT06513650