Clinical trial NCT02137278: Stop Vasodepressor Drugs in Reflex Syncope
Official title: Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypotensive Syncope
Keywords: Syncope
Presyncope
Vasoactive drugs
Hypotension
Carotid sinus massage
Tilt table test
Lead sponsor: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of syncope or presyncope and adverse events
timeFrame: From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Secondary outcomes:
measure: Syncope
timeFrame: From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years
measure: Presyncope
timeFrame: From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Other outcomes:
measure: Acute study
timeFrame: 1 month
Locations:
city: Lavagna
country: Italy
facility: Dipartimento di Cardiologia, Ospedali del Tigullio
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.