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Completed

NCT Number: NCT02137278

Stop Vasodepressor Drugs in 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.

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Key information

Conditions

Hypotensive Syncope Cardiovascular Diseases Consciousness Disorders Hypotension Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dipartimento di Cardiologia, Ospedali del Tigullio

Lavagna, 16032, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasoactive drug therapies

Drug

Continue current vasoactive therapy

Other names: Antihypertensive, Nitrates, Alpha-antagonists, Diuretics, Neuroleptic antidepressant, L-dopa antagonists

Stop/reduce vasoactive drugs

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Other

Registry information

Official study title

Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope

Acronym: STOP-VD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 13, 2014
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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