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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Calgary
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier:
NCT01456481
First received: October 14, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Vasovagal Syncope
Drug: midodrine hydrochloride
Drug: matching placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • The primary outcome measure will be the proportion of patients having at least one syncope recurrence. [ Time Frame: 1 year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A secondary outcome will be the time between the first and second syncope recurrences. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • A secondary outcome will be the frequency of syncopal spells. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
  • A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456481

Contacts
Contact: Dr. Robert S Sheldon, MD, PhD 403-220-8191 sheldon@ucalgary.ca

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Satish R Raj, MD    615-343-6499      
Principal Investigator: Satish R Raj, MD         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Dr. Robert S Sheldon, MD, PhD    403-220-8191    sheldon@ucalgary.ca   
Principal Investigator: Dr. Robert S Sheldon, MD PhD         
Alberta Health Services - Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Evan Lockwood, MD    780-735-4489      
Principal Investigator: Evan Lockwood, MD         
Canada, New Brunswick
New Brunswick Heart Centre Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Ricardo Bessoudo, MD    506-648-6000      
Principal Investigator: Ricardo Bessoudo, MD         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: David Birnie, MD    613-761-4705      
Principal Investigator: David Birnie, MD         
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Felix Ayala-Paredes, MD    819-346-1110 ext 12826      
Principal Investigator: Felix Ayala-Paredes, MD         
Sponsors and Collaborators
Dr. Bob Sheldon
Vanderbilt University
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: October 14, 2011
Last Updated: January 9, 2014
Health Authority: Canada: Health Canada
United States: Institutional Review Board

Keywords provided by University of Calgary:
reflex fainting
vasovagal syncope
midodrine

Additional relevant MeSH terms:
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
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 09, 2014