Therapy for patients with hypotensive syncope
Mechanism-based Therapy of Hypotensive Syncope
Istituto Auxologico Italiano · NCT06513650
This study is testing a new treatment approach to see if changing or adding medications can help people with low blood pressure feel better and have fewer fainting spells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano (other) |
| Locations | 9 sites (Marseille and 8 other locations) |
| Trial ID | NCT06513650 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a therapeutic strategy to increase 24-hour systolic blood pressure in patients suffering from hypotensive syncope. It consists of two parallel substudies: one focusing on deprescribing antihypertensive medications in patients whose syncope is related to these drugs, and the other on adding fludrocortisone for patients with drug-unrelated hypotension. The study will monitor patients over a year to assess the reduction in syncope occurrences through 24-hour ambulatory blood pressure monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe, recurrent reflex syncope that is resistant to lifestyle changes and education, and who have been diagnosed with hypotensive syncope.
Not a fit: Patients under 18, those with cardioinhibitory reflex syncope, or those with competing causes of syncope may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of syncope episodes in affected patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in managing syncope through blood pressure modulation.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Marseille and 8 other locations
- University of marseille Aix en Provence — Marseille, France (RECRUITING)
- IRCCS Istituto Auxologico Italiano — Milan, MI, Italy (RECRUITING)
- IRCCS Istituto Auxologico Italiano — Milan, MI, Italy (RECRUITING)
- University of Florence — Florence, Italy (RECRUITING)
- ospdali del Tigullio — Lavagna, Italy (RECRUITING)
- Università della Campania Vamvitelli — Naples, Italy (RECRUITING)
- AMC Universisty of Amsterdam — Amsterdam, Netherlands (RECRUITING)
- University of Barcelona Vall d'Ebron — Barcelona, Spain (NOT_YET_RECRUITING)
- Karolinska Institut — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Michele Brignole, MD Cardiologist
- Email: m.brignole@auxologico.it
- Phone: +3204391422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Syncope, Vasovagal, Neurally-Mediated