Mechanism-based Therapy of Hypotensive Syncope

NCT06513650 | Recruiting

• 1 other identifier: 09C408
• Study Type: observational
• Target: 140
• Locations: 5 countries
• Sites: 9

Brief 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.

Conditions

Syncope, Vasovagal, Neurally-Mediated

Outcome Measures

Primary Outcomes (1)

• Time to first syncope recurrenceSyncope

  • The primary endpoint of the Drug-deprescribing subgroup is the comparison of syncopal recurrences (time to first recurrence and syncope burden) at one year in patients who achieved a mean absolute value of ≥134 mmHg and/or an increase ≥12 mmHg of 24-hour SBP on ABPM2 (Target) with those of patients who did not (No target). • The primary endpoint of the Drug-addition subgroup is the comparison of syncopal recurrences (time to first recurrence and syncope burden) at one year in patients who achieved a mean absolute value of ≥116 mmHg and an increase of ≥9 mmHg of 24-hour SBP on ABPM2 (Target) with those of patients who did not (No target).

  4 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Age \<18 years 2. Cardioinhibitory reflex syncope during SCAFA tests 3. Competing causes of syncope 4. Severe cardiac disease, previous stroke or transient ischaemic attack. 5. Patients who refused drug therapy 6. Non-severe forms of syncope, i.e., patients with rare and mild episodes occurring in low-risk situations in the presence of distinct and preventable triggers. 7. Contraindication to fludrocortisone

You may qualify if:

• 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.
• \. Clinical indication to deprescribing of antihypertensive drugs or to prescribing of fludrocortisone therapy, as appropriate, according to the clinical practice of the investigator

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (9)

University of marseille Aix en Provence

Marseille, France

RECRUITING

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, Italy

RECRUITING

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, 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

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michele Brignole, MD Cardiologist

CONTACT

+3204391422; m.brignole@auxologico.it

Antonella Groppelli, MD

CONTACT

+393388732063; a.groppelli@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); NL (1); IT (5); ES (1); FR (1)