search
Back to results

Stop Vasodepressor Drugs in Reflex Syncope (STOP-VD)

Primary Purpose

Hypotensive Syncope

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Vasoactive drug therapies
Stop/reduce vasoactive drugs
Sponsored by
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotensive Syncope focused on measuring Syncope, Presyncope, Vasoactive drugs, Hypotension, Carotid sinus massage, Tilt table test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dipartimento di Cardiologia, Ospedali del Tigullio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stop/reduce vasoactive drugs

Vasoactive drug therapy

Arm Description

Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment

Continue current vasoactive therapy

Outcomes

Primary Outcome Measures

Recurrence of syncope or presyncope and adverse events
Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events

Secondary Outcome Measures

Syncope
Recurrence of syncope
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

Full Information

First Posted
May 1, 2014
Last Updated
December 28, 2015
Sponsor
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
search

1. Study Identification

Unique Protocol Identification Number
NCT02137278
Brief Title
Stop Vasodepressor Drugs in Reflex Syncope
Acronym
STOP-VD
Official Title
Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Multidisciplinare per lo Studio della Sincope

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotensive Syncope
Keywords
Syncope, Presyncope, Vasoactive drugs, Hypotension, Carotid sinus massage, Tilt table test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stop/reduce vasoactive drugs
Arm Type
Active Comparator
Arm Description
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
Arm Title
Vasoactive drug therapy
Arm Type
Experimental
Arm Description
Continue current vasoactive therapy
Intervention Type
Drug
Intervention Name(s)
Vasoactive drug therapies
Other Intervention Name(s)
Antihypertensive, Nitrates, Alpha-antagonists, Diuretics, Neuroleptic antidepressant, L-dopa antagonists
Intervention Description
Continue current vasoactive therapy
Intervention Type
Other
Intervention Name(s)
Stop/reduce vasoactive drugs
Other Intervention Name(s)
Antihypertensive, Nitrates, Alpha-antagonists, Diuretics, Neuroleptic antidepressant, L-dopa antagonists
Intervention Description
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.
Primary Outcome Measure Information:
Title
Recurrence of syncope or presyncope and adverse events
Description
Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events
Time Frame
From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Secondary Outcome Measure Information:
Title
Syncope
Description
Recurrence of syncope
Time Frame
From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years
Title
Presyncope
Description
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
Time Frame
From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Other Pre-specified Outcome Measures:
Title
Acute study
Description
Quality of life assessed by means of the Specific symptom Scale - Orthostatic Hypotension questionnaire. Results of carotid sinus massage and tilt table test
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing Competing diagnosis of syncope different from hypotensive reflex syncope Reflex syncope with negative response to carotid sinus massage and tilt table test Cardioinhibitory reflex syncope which requires permanent cardiac pacing Severe hypertension which requires treatment (>150/95) Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure Cardiac hypotensive therapy in order to prevent recurrences Previous stroke or transient ischemic attacks
Facility Information:
Facility Name
Dipartimento di Cardiologia, Ospedali del Tigullio
City
Lavagna
ZIP/Postal Code
16032
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
7572635
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. doi: 10.1016/s0002-9149(99)80207-0. No abstract available.
Results Reference
background
PubMed Identifier
24058183
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.
Results Reference
result
PubMed Identifier
17010806
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 Cardiol. 2006 Oct 3;48(7):1425-32. doi: 10.1016/j.jacc.2006.06.052. Epub 2006 Sep 14.
Results Reference
result
PubMed Identifier
9704688
Citation
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.
Results Reference
result

Learn more about this trial

Stop Vasodepressor Drugs in Reflex Syncope

We'll reach out to this number within 24 hrs