Actively Recruiting

Age: 18Years +
All Genders
NCT06513650

Mechanism-based Therapy of Hypotensive Syncope

Led by Istituto Auxologico Italiano · Updated on 2024-07-22

140

Participants Needed

9

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mechanism-based Therapy of Hypotensive Syncope

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Clinical diagnosis of severe, recurrent reflex syncope not improved by education and lifestyle measures according to ESC guidelines
  • Diagnosis of hypotensive syncope defined by persistent or intermittent low blood pressure during 24-hour ambulatory blood pressure monitoring and/or syncope reproduced during cardiovascular autonomic function tests (carotid sinus massage, active stand test, and head-up tilt test)
  • Clinical indication to reduce antihypertensive drugs or prescribe fludrocortisone therapy as appropriate
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Cardioinhibitory reflex syncope during cardiovascular autonomic function tests
  • Presence of other competing causes of syncope
  • Severe cardiac disease, previous stroke, or transient ischemic attack
  • Patients who refuse drug therapy
  • Non-severe syncope forms with rare, mild episodes occurring in low-risk situations with clear triggers
  • Contraindication to fludrocortisone therapy

AI-Screening

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Trial Site Locations

Total: 9 locations

1

University of marseille Aix en Provence

Marseille, France

Actively Recruiting

2

IRCCS Istituto Auxologico Italiano

Milan, MI, Italy, 16149

Actively Recruiting

3

IRCCS Istituto Auxologico Italiano

Milan, MI, Italy, 16149

Actively Recruiting

4

University of Florence

Florence, Italy

Actively Recruiting

5

ospdali del Tigullio

Lavagna, Italy

Actively Recruiting

6

Università della Campania Vamvitelli

Naples, Italy

Actively Recruiting

7

AMC Universisty of Amsterdam

Amsterdam, Netherlands

Actively Recruiting

8

University of Barcelona Vall d'Ebron

Barcelona, Spain

Not Yet Recruiting

9

Karolinska Institut

Stockholm, Sweden

Actively Recruiting

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Research Team

M

Michele Brignole, MD Cardiologist

CONTACT

A

Antonella Groppelli, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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