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Stop Vasodepressor Drugs in Reflex Syncope (STOP-VD)

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ClinicalTrials.gov Identifier: NCT02137278
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Multidisciplinare per lo Studio della Sincope

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.

Condition or disease Intervention/treatment Phase
Hypotensive Syncope Drug: Vasoactive drug therapies Other: Stop/reduce vasoactive drugs Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arm Intervention/treatment
Active Comparator: Stop/reduce vasoactive drugs
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
Other: Stop/reduce vasoactive drugs
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.
Other Names:
  • Antihypertensive
  • Nitrates
  • Alpha-antagonists
  • Diuretics
  • Neuroleptic antidepressant
  • L-dopa antagonists

Experimental: Vasoactive drug therapy
Continue current vasoactive therapy
Drug: Vasoactive drug therapies
Continue current vasoactive therapy
Other Names:
  • Antihypertensive
  • Nitrates
  • Alpha-antagonists
  • Diuretics
  • Neuroleptic antidepressant
  • L-dopa antagonists




Primary Outcome Measures :
  1. Recurrence of syncope or presyncope 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 ]
    Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events


Secondary Outcome Measures :
  1. 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 ]
    Recurrence of syncope

  2. Presyncope [ Time Frame: 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 Outcome Measures:
  1. Acute study [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137278


Locations
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Italy
Dipartimento di Cardiologia, Ospedali del Tigullio
Lavagna, Italy, 16032
Sponsors and Collaborators
Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Publications of Results:
Other Publications:
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Responsible Party: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
ClinicalTrials.gov Identifier: NCT02137278     History of Changes
Other Study ID Numbers: ASL4/CARD/01
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Keywords provided by Gruppo Italiano Multidisciplinare per lo Studio della Sincope:
Syncope
Presyncope
Vasoactive drugs
Hypotension
Carotid sinus massage
Tilt table test
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Levodopa
Antipsychotic Agents
Antidepressive Agents
Diuretics
Antihypertensive Agents
Psychotropic Drugs
Natriuretic Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tranquilizing Agents
Central Nervous System Depressants