Mechanism-based Therapy of Hypotensive Syncope

Status: Recruiting
Location: See all (9) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University of marseille Aix en Provence
RECRUITING
Marseille
Italy
University of Florence
RECRUITING
Florence
ospdali del Tigullio
RECRUITING
Lavagna
IRCCS Istituto Auxologico Italiano
RECRUITING
Milan
IRCCS Istituto Auxologico Italiano
RECRUITING
Milan
Università della Campania Vamvitelli
RECRUITING
Naples
Netherlands
AMC Universisty of Amsterdam
RECRUITING
Amsterdam
Spain
University of Barcelona Vall d'Ebron
NOT_YET_RECRUITING
Barcelona
Sweden
Karolinska Institut
RECRUITING
Stockholm
Contact Information
Primary
Michele Brignole, MD Cardiologist
m.brignole@auxologico.it
+3204391422
Backup
Antonella Groppelli, MD
a.groppelli@auxologico.it
+393388732063
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 140
Treatments
Drug deprescring and drug addition
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-deprescribing substudy wants to assess a strategy aimed to increase BP by deprescribing of hypotensive drugs in hypertensive patients affected by drug-related syncope, and;~2. the Drug-addition substudy wants to assess a therapeutic strategy aimed at increasing BP with fludrocortisone in syncopal patients with drug-unrelated permanent or intermittent hypotension.
Sponsors
Leads: Istituto Auxologico Italiano

This content was sourced from clinicaltrials.gov

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