Stop Vasodepressor Drugs in Reflex Syncope (STOP-VD)

Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Status and phase: Completed; Phase 3

Conditions: Hypotensive Syncope

Treatments: Other: Stop/reduce vasoactive drugs; Drug: Vasoactive drug therapies

Study type: Interventional

Funder types: Other

Identifiers

NCT02137278

ASL4/CARD/01

Details and patient eligibility

About

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

Full description

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

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing
2. Competing diagnosis of syncope different from hypotensive reflex syncope
3. Reflex syncope with negative response to carotid sinus massage and tilt table test
4. Cardioinhibitory reflex syncope which requires permanent cardiac pacing
5. Severe hypertension which requires treatment (>150/95)
6. Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure
7. Cardiac hypotensive therapy in order to prevent recurrences
8. Previous stroke or transient ischemic attacks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Stop/reduce vasoactive drugs

Active Comparator group

Description:

Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment

Treatment:

Other: Stop/reduce vasoactive drugs

Vasoactive drug therapy

Experimental group

Description:

Continue current vasoactive therapy

Treatment:

Drug: Vasoactive drug therapies