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Stop Vasodepressor Drugs in Reflex Syncope

NCT ID: NCT02137278

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

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

Conditions

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Hypotensive Syncope

Keywords

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Syncope Presyncope Vasoactive drugs Hypotension Carotid sinus massage Tilt table test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stop/reduce vasoactive drugs

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

Group Type ACTIVE_COMPARATOR

Stop/reduce vasoactive drugs

Intervention Type OTHER

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

Vasoactive drug therapy

Continue current vasoactive therapy

Group Type EXPERIMENTAL

Vasoactive drug therapies

Intervention Type DRUG

Continue current vasoactive therapy

Interventions

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Vasoactive drug therapies

Continue current vasoactive therapy

Intervention Type DRUG

Stop/reduce vasoactive drugs

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

Intervention Type OTHER

Other Intervention Names

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Antihypertensive Nitrates Alpha-antagonists Diuretics Neuroleptic antidepressant L-dopa antagonists Antihypertensive Nitrates Alpha-antagonists Diuretics Neuroleptic antidepressant L-dopa antagonists

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Multidisciplinare per lo Studio della Sincope

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dipartimento di Cardiologia, Ospedali del Tigullio

Lavagna, , Italy

Site Status

Countries

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Italy

References

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Gaggioli G, Brignole M, Menozzi C, Devoto G, Oddone D, Gianfranchi L, Gostoli E, Bottoni N, Lolli G. A positive response to head-up tilt testing predicts syncopal recurrence in carotid sinus syndrome patients with permanent pacemakers. Am J Cardiol. 1995 Oct 1;76(10):720-2. doi: 10.1016/s0002-9149(99)80207-0. No abstract available.

Reference Type BACKGROUND
PMID: 7572635 (View on PubMed)

Solari D, Maggi R, Oddone D, Solano A, Croci F, Donateo P, Brignole M. Clinical context and outcome of carotid sinus syndrome diagnosed by means of the 'method of symptoms'. Europace. 2014 Jun;16(6):928-34. doi: 10.1093/europace/eut283. Epub 2013 Sep 20.

Reference Type RESULT
PMID: 24058183 (View on PubMed)

Podoleanu C, Maggi R, Brignole M, Croci F, Incze A, Solano A, Puggioni E, Carasca E. Lower limb and abdominal compression bandages prevent progressive orthostatic hypotension in elderly persons: a randomized single-blind controlled study. J Am Coll Cardiol. 2006 Oct 3;48(7):1425-32. doi: 10.1016/j.jacc.2006.06.052. Epub 2006 Sep 14.

Reference Type RESULT
PMID: 17010806 (View on PubMed)

Brignole M, Menozzi C, Gaggioli G, Musso G, Foglia-Manzillo G, Mascioli G, Fradella G, Bottoni N, Mureddu R. Effects of long-term vasodilator therapy in patients with carotid sinus hypersensitivity. Am Heart J. 1998 Aug;136(2):264-8. doi: 10.1053/hj.1998.v136.89911.

Reference Type RESULT
PMID: 9704688 (View on PubMed)

Other Identifiers

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ASL4/CARD/01

Identifier Type: -

Identifier Source: org_study_id