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Trial record 1 of 1 for:    NCT01456481
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Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (POST 4)

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ClinicalTrials.gov Identifier: NCT01456481
Recruitment Status : Active, not recruiting
First Posted : October 20, 2011
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary

Brief Summary:

About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. There is considerable lower level evidence that it might prevent vasovagal syncope.

The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.


Condition or disease Intervention/treatment Phase
Vasovagal Syncope Drug: midodrine hydrochloride Drug: matching placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (Post 4)
Study Start Date : November 2011
Actual Primary Completion Date : December 20, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Active Comparator: midodrine hydrochloride pills Drug: midodrine hydrochloride
Target dose is midodrine hydrochloride or placebo pills 10 mg three times a day for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
Other Name: Brand name for the drug is midodrine.

Placebo Comparator: oral placebo or sugar pill Drug: midodrine hydrochloride
Target dose is midodrine hydrochloride or placebo pills 10 mg three times a day for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
Other Name: Brand name for the drug is midodrine.

Drug: matching placebo
The target dose in this study is 10mg q4h x3 for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.




Primary Outcome Measures :
  1. The primary outcome measure will be the proportion of patients having at least one syncope recurrence. [ Time Frame: 1 year. ]

Secondary Outcome Measures :
  1. A secondary outcome will be the time between the first and second syncope recurrences. [ Time Frame: 1 year ]
  2. A secondary outcome will be the frequency of syncopal spells. [ Time Frame: 1 year ]
  3. A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). [ Time Frame: 1 year. ]
  4. A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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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 will be eligible if they have:

    • ≥2 syncopal spells in the year preceding enrolment, and
    • ≥ -2 points on the Syncope Symptom Score for Structurally Normal hearts, and
    • Age ≥ 18 years with informed consent.

Exclusion Criteria:

  • Patients will be excluded if they have:

    • other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome,
    • an inability to give informed consent,
    • important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia,
    • hypertrophic cardiomyopathy,
    • a permanent pacemaker,
    • a seizure disorder,
    • urinary retention,
    • hypertension defined as >140/90 mm Hg,
    • hepatic disease,
    • glaucoma or
    • a 5-minute stand test resulting in diagnoses of Postural Orthostatic Tachycardia Syndrome or Orthostatic Hypotension.

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): NCT01456481


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Alberta Health Services - Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Red Deer Regional Hospital
Red Deer, Alberta, Canada, T4N 4E7
Canada, British Columbia
Victoria Cardiac Arrythmia Trials
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
St. Boniface General Hospital
St. Boniface, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
New Brunswick Heart Centre
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Queen E II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A6
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Hopital Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Prairie Vascular Research Network/Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Saskatoon Cardiology Consultants/Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7K 3H1
Poland
Medical University of Lodz
Lodz, Poland, 93-005
Sponsors and Collaborators
Dr. Bob Sheldon
Vanderbilt University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary
ClinicalTrials.gov Identifier: NCT01456481     History of Changes
Other Study ID Numbers: CIHR#243314
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

Keywords provided by Dr. Bob Sheldon, University of Calgary:
reflex fainting
vasovagal syncope
midodrine

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
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action