Hypotensive Syncope
Conditions
Keywords
Syncope, Presyncope, Vasoactive drugs, Hypotension, Carotid sinus massage, Tilt table test
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
Interventions
Continue current vasoactive therapy
OTHERStop/reduce vasoactive drugs
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.
Sponsors
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of syncope or presyncope 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 | Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Syncope | From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years | Recurrence of syncope |
| Presyncope | From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute study | 1 month | Quality of life assessed by means of the Specific symptom Scale - Orthostatic Hypotension questionnaire. Results of carotid sinus massage and tilt table test |
Countries
Italy
Outcome results
None listed