Stop Vasodepressor Drugs in Reflex Syncope

Study Overview
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Brief Summary
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Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.

Detailed Description
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Several drugs which are commonly used in clinical practice, such as antihypertensive, antiarrhythmic and psychiatric drugs, are associated with orthostatic hypotension and syncope. This phenomenon is much more evident in the elderly and with multiple therapies. The present study was aimed to investigate, in patients affected by reflex syncope, the clinical effects (reduction in syncope recurrence and associated symptoms) and the laboratory tests (negativization of carotid sinus massage and tilt table test) when such drugs are discontinued or reduced

Official Title
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Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope

Conditions
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Hypotensive Syncope

Intervention / Treatment
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* Drug: Vasoactive drug therapies
* Other: Stop/reduce vasoactive drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients assuming chronic (>1 year) vasoactive therapy affected by reflex recurrent (>2 episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilt table test and/or carotid sinus massage Exclusion Criteria: Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing Competing diagnosis of syncope different from hypotensive reflex syncope Reflex syncope with negative response to carotid sinus massage and tilt table test Cardioinhibitory reflex syncope which requires permanent cardiac pacing Severe hypertension which requires treatment (>150/95) Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure Cardiac hypotensive therapy in order to prevent recurrences Previous stroke or transient ischemic attacks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stop/reduce vasoactive drugs<br>Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment | Other: Stop/reduce vasoactive drugs<br>* Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.<br>* Other names: L-dopa antagonists;|
| Experimental: Vasoactive drug therapy<br>Continue current vasoactive therapy | Drug: Vasoactive drug therapies<br>* Continue current vasoactive therapy<br>* Other names: L-dopa antagonists;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of syncope or presyncope and adverse events | Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events | From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syncope | Recurrence of syncope | From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years | 
| Presyncope | Burden of presyncope, measured as number of episodes of presyncope/s per month assessed up to 2 years by mean of a patient's diary | From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syncope, Presyncope, Vasoactive drugs, Hypotension, Carotid sinus massage, Tilt table test