Stop Vasodepressor Drugs in Reflex Syncope

Phase 3

Completed

• Conditions: Hypotensive Syncope
• Interventions: Other: Stop/reduce vasoactive drugs; Drug: Vasoactive drug therapies

• Registration Number: NCT02137278
• Lead Sponsor: Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Brief Summary

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

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-10
• Study First Posted: 2014-05-13
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stop/reduce vasoactive drugs	Stop/reduce vasoactive drugs	Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
Vasoactive drug therapy	Vasoactive drug therapies	Continue current vasoactive therapy

Primary Outcome Measures

Name	Time	Method
Recurrence of syncope or presyncope 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	Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events

Secondary Outcome Measures

Name	Time	Method
Syncope	From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years	Recurrence of syncope
Presyncope	From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years	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

Trial Locations

Locations (1)

Dipartimento di Cardiologia, Ospedali del Tigullio; 🇮🇹 Lavagna, Italy