Actively Recruiting
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
Eligibility Criteria
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
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
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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