Stop Vasodepressor Drugs in Reflex Syncope

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
• Treatments: Antidepressive Agents; Antihypertensive Agents; Antipsychotic Agents; Diuretics; Levodopa

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