Suspension of vasoactive drugs in reflex vasodepressive syncope: a clinical study

Suspension of vasoactive drugs in reflex vasodepressive syncope: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004919-43-IT

Enrollment

Registered

2014-04-28

Start date

2014-05-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasodepressive neuroreflex syncope MedDRA version: 16.1 Level: LLT Classification code 10042777 Term: Syncope vasovagal System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1 Level: PT Classification code 10042772 Term: Syncope System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.1 Level: LLT Classification code 10067550 Term: Neurally mediated syncope System Organ Class: 10029205 - Nervous system disorders

Interventions

Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form: Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients on chronic therapy (> 1 year) with vasoactive drugs with recurrent reflex syncope (= 2 episodes / last year), for who it has been demonstrated positive tilt test or has been diagnosed with carotid sinus syndrome with predominantly vasodepressor component (form vasodepressor or mixed). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1 - Patients with a diagnosis of symptomatic orthostatic hypotension, defined as a reduction in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg during the first 3 minutes after orthostatism. 2 - Patients with a diagnosis of syncope different from the vasodepressor reflex syncope 3 - Patients with reflex syncope with negativity of both carotid sinus massage and tilt test 4 - Patients with a clinical diagnosis of reflex syncope with cardioinihibiting component that requires pacemaker implantation 5 - Patients with poorly controlled hypertension (> 150/95) 6 - Patients with heart failure in the suspension / reduction therapy carries the risk of worsening the heart failure 7 - Patients with cardiac arrhythmias in which the suspension / reduction of antiarrhythmic therapy carries the risk of worsening arrhythmias 8 - Patients with prior TIA or stroke.

Design outcomes

Primary

Measure	Time frame
Main Objective: The study is aimed to investigate the clinical effects (reduction in the number of syncope and symptoms associated with syncope) and instrumental (negativity of tilt testing and / or carotid sinus massage) resulting from the suspension / reduction of vasoactive drugs in patients with vasodepressor reflex syncope diagnosed by carotid sinus massage or tilt test.;Secondary Objective: Not applicable;Primary end point(s): Recurrence-free interval of syncope, syncope, stroke, fatal and nonfatal stroke. The range will be considered as the time between enrollment (the index event) and the date of onset of the first of the three events that represent the adverse event. The period of observation of patients in which the closure of the study will not occur adverse events, will be censored to the date of the last visit available.;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: The study is aimed to investigate the clinical effects (reduction in the number of syncope and symptoms associated with syncope) and instrumental (negativity of tilt testing and / or carotid sinus massage) resulting from the suspension / reduction of vasoactive drugs in patients with vasodepressor reflex syncope diagnosed by carotid sinus massage or tilt test.;Secondary Objective: Not applicable;Primary end point(s): Recurrence-free interval of syncope, syncope, stroke, fatal and nonfatal stroke. The range will be considered as the time between enrollment (the index event) and the date of onset of the first of the three events that represent the adverse event. The period of observation of patients in which the closure of the study will not occur adverse events, will be censored to the date of the last visit available.;Timepoint(s) of evaluation of this end point: 1 month

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Secondary

Measure	Time frame
Secondary end point(s): 1 - Recurrence-free interval of syncope. The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . 2 - Recurrence-free interval of pre syncope . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . 3 - Recurrence-free interval of fatal stroke . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . 4 - Recurrence-free interval of recurrent nonfatal stroke . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): 1 - Recurrence-free interval of syncope. The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . 2 - Recurrence-free interval of pre syncope . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . 3 - Recurrence-free interval of fatal stroke . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . 4 - Recurrence-free interval of recurrent nonfatal stroke . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . ;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Italy

Contacts

Public ContactCentro per lo Studio della Sincope

SOD Medicina e Cardiologia Geriatrica - Università di Firenze e AOUCareggi

aungar@unifi.it+390554271467

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026