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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stop/reduce vasoactive drugs | Active Comparator | Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment |
|
| Vasoactive drug therapy | Experimental | Continue current vasoactive therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasoactive drug therapies | Drug | Continue current vasoactive therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of syncope or presyncope and adverse events | Combined end-point of rate of patients with recurrence of (pre)syncope 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Syncope | Recurrence of syncope | From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years |
| Presyncope | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute study | Quality of life assessed by means of the Specific symptom Scale - Orthostatic Hypotension questionnaire. Results of carotid sinus massage and tilt table test | 1 month |
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Cardiologia, Ospedali del Tigullio | Lavagna | 16032 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7572635 | Background | 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. | |
| 24058183 |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000959 | Antihypertensive Agents |
| D009566 | Nitrates |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Stop/reduce vasoactive drugs | Other | Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment. |
|
|
| From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years |
| 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. |
| 17010806 | Result | 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. |
| 9704688 | Result | 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. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 | Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |