Hypotensive Syncope | Stop Vasodepressor Drugs in Reflex Syncope
Hypotensive Syncope research study
What is the primary objective of this study?
Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Vasoactive drug therapiesContinue current vasoactive therapy
Other:Stop/reduce vasoactive drugsDiscontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Stop/reduce vasoactive drugsDiscontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
Vasoactive drug therapyContinue current vasoactive therapy
Start Date: March 2014
Completed Date: December 2015
Phase: Phase 3
Primary Outcome: Recurrence of syncope or presyncope and adverse events
Secondary Outcome: Syncope
Study sponsors, principal investigator, and references
Lead Sponsor: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
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.
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.
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. Epub 2006 Sep 14.
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.