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

Conditions: MedDRA version: 16.1Level: PTClassification code 10042772Term: SyncopeSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.1Level: LLTClassification code 10067550Term: Neurally mediated syncopeSystem Organ Class: 10029205 - Nervous system disorders
Vasodepressive neuroreflex syncope
MedDRA version: 16.1Level: LLTClassification code 10042777Term: Syncope vasovagalSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-004919-43-IT

Lead Sponsor: SOD Medicina e Cardiologia Geriatrica, Centro per lo Studio della Sincope - Università degli Studi di Firenze-AOUCareggi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.