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POST 4: Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV

Sponsor
Dr. Bob Sheldon (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01456481
Collaborator
Vanderbilt University (Other)
134
Enrollment
17
Locations
2
Arms
122
Duration (Months)
7.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: midodrine hydrochloride
  • Drug: matching placebo
 Phase 4

Study Design

Study Type:
Interventional
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 :
Nov 1, 2011
Actual Primary Completion Date :
Dec 20, 2018
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome measure will be the proportion of patients having at least one syncope recurrence. [1 year.]

    Secondary Outcome Measures

    1. A secondary outcome will be the time between the first and second syncope recurrences. [1 year]

    2. A secondary outcome will be the frequency of syncopal spells. [1 year]

    3. A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). [1 year.]

    4. A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Dr. Bob Sheldon
    • Vanderbilt University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary
    ClinicalTrials.gov Identifier:
    NCT01456481
    Other Study ID Numbers:
    • CIHR#243314
    First Posted:
    Oct 20, 2011
    Last Update Posted:
    Apr 29, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary
    reflex fainting
    vasovagal syncope
    midodrine
    Additional relevant MeSH terms:
    Syncope
    Syncope, Vasovagal
    Midodrine

    Study Results

    No Results Posted as of Apr 29, 2021