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Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope (POST6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500732
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Cardiac Arrhythmia Network of Canada
Information provided by (Responsible Party):
Dr. Satish Raj, University of Calgary

Brief Summary:
Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.

Condition or disease Intervention/treatment Phase
Vasovagal Syncope Drug: Atomoxetine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study drug was encapsulated in opaque capsules by study personnel not involved in the day to day operations of the study.
Primary Purpose: Treatment
Official Title: A Proof of Principle Study of Atomoxetine for the Prevention of Vasovagal Syncope (VVS): POST6
Study Start Date : July 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test.
Drug: Placebo
oral placebo capsule designed to blind the atomoxetine intervention

Active Comparator: Atomoxetine
Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.
Drug: Atomoxetine
40mg PO the night before and the morning of the study tilt table test.
Other Name: Strattera




Primary Outcome Measures :
  1. Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia [ Time Frame: 1 hour post start of head up tilt ]

Secondary Outcome Measures :
  1. Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia [ Time Frame: 1 hour post start of head up tilt ]
  2. Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope [ Time Frame: From baseline to within 1 hour post start of head up tilt ]
  3. Cardiac Index (From the Continuous BP Monitor) During Presyncope [ Time Frame: From baseline to within 1 hour post start of head up tilt ]
  4. Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope [ Time Frame: From baseline to within 1 hour post start of head up tilt ]


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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:

  • 1 or more syncopal spells in the year preceding enrolment
  • More than -2 points on the Calgary Syncope Symptom Score
  • Age ≥18 years with informed consent

Exclusion Criteria:

  • Other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome
  • Inability to give informed consent
  • important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia.
  • hypertrophic cardiomyopathy
  • a permanent pacemaker
  • a seizure disorder
  • hypertension defined as >150/90 mm Hg
  • pregnancy
  • glaucoma
  • medications with known effects on blood pressure
  • Known hypersensitivity to atomoxetine and derivatives

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): NCT02500732


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
University of Calgary
Cardiac Arrhythmia Network of Canada
Investigators
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Principal Investigator: Satish R Raj, MD MSCI University of Calgary
  Study Documents (Full-Text)

Documents provided by Dr. Satish Raj, University of Calgary:
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Responsible Party: Dr. Satish Raj, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02500732    
Other Study ID Numbers: POST6
First Posted: July 16, 2015    Key Record Dates
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020
Last Verified: April 2020
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
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs