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Search / Trial NCT06513650

Mechanism-based Therapy of Hypotensive Syncope

Launched by ISTITUTO AUXOLOGICO ITALIANO · Jul 16, 2024

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people who experience episodes of fainting, known as hypotensive syncope, which is often triggered by low blood pressure. The goal is to see if a special treatment can help increase blood pressure over a 24-hour period and reduce the number of fainting episodes in patients who have not improved with regular lifestyle changes or education. Participants will have their blood pressure monitored for a day and undergo specific tests to see how their bodies respond.

To be eligible for this trial, you must be over 18 years old and have severe, frequent fainting episodes that haven't improved with standard care. You also need to have a diagnosis of low blood pressure that can be measured during a 24-hour monitoring period or through certain tests. If you join the study, you can expect to receive closer monitoring of your condition and potentially new treatment options. The trial is currently looking for participants, and anyone interested should talk to their healthcare provider for more information.

Gender

ALL

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 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:
  • -

About Istituto Auxologico Italiano

Istituto Auxologico Italiano is a prominent Italian research institute dedicated to advancing medical science and improving patient care through innovative clinical research. With a strong focus on metabolic diseases, cardiovascular health, and neuropsychological disorders, the institute integrates clinical practice with cutting-edge research to foster the development of new therapeutic strategies. Committed to ethical standards and patient safety, Istituto Auxologico Italiano collaborates with various national and international partners, contributing significantly to the global medical community while ensuring high-quality care and support for its patients.

Locations

Florence, Italy

Stockholm, Sweden

Milan, Mi, Italy

Marseille, France

Lavagna, Italy

Naples, Italy

Amsterdam, Netherlands

Barcelona, Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported