Hypotensive Syncope Clinical Trial
— STOP-VDOfficial title:
Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope
Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Dipartimento di Cardiologia, Ospedali del Tigullio | Lavagna |
| Lead Sponsor | Collaborator |
|---|---|
| Gruppo Italiano Multidisciplinare per lo Studio della Sincope |
Italy,
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. — View 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. — View 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 Cardio — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Primary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years | No |