Stop Vasodepressor Drugs in Reflex Syncope

Last updated: December 28, 2015
Sponsor: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Overall Status: Completed

Phase

3

Condition

Orthostatic Hypotension

Cataplexy

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT02137278
ASL4/CARD/01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients assuming chronic (>1 year) vasoactive therapy affected by reflex recurrent (>2episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilttable test and/or carotid sinus massage

Exclusion

Exclusion Criteria:

  1. Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during thefirst 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 acuteheart failure

  7. Cardiac hypotensive therapy in order to prevent recurrences

  8. Previous stroke or transient ischemic attacks

Study Design

Total Participants: 58
Study Start date:
March 01, 2014
Estimated Completion Date:
December 31, 2015

Study 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

Connect with a study center

  • Dipartimento di Cardiologia, Ospedali del Tigullio

    Lavagna, 16032
    Italy

    Site Not Available

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