Clinical trial NCT01456481: Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV
Official title: Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (Post 4)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Vasovagal Syncope
Keywords: reflex fainting
vasovagal syncope
midodrine
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2011-10-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary outcome measure will be the proportion of patients having at least one syncope recurrence.
timeFrame: 1 year.
Secondary outcomes:
measure: A secondary outcome will be the time between the first and second syncope recurrences.
timeFrame: 1 year
measure: A secondary outcome will be the frequency of syncopal spells.
timeFrame: 1 year
measure: A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).
timeFrame: 1 year.
measure: A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Health Services - Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital
state: Alberta
city: Victoria
country: Canada
facility: Victoria Cardiac Arrythmia Trials
state: British Columbia
city: St. Boniface
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Saint John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
city: Halifax
country: Canada
facility: Queen E II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Hopital Sacre Coeur de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Regina
country: Canada
facility: Prairie Vascular Research Network/Regina General Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cardiology Consultants/Royal University Hospital
state: Saskatchewan
city: Lodz
country: Poland
facility: Medical University of Lodz
Study officials:
References:
citation: Sheldon R, Faris P, Tang A, Ayala-Paredes F, Guzman J, Marquez M, Morillo CA, Krahn AD, Kus T, Ritchie D, Safdar S, Maxey C, Raj SR; POST 4 investigators. Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial. Ann Intern Med. 2021 Oct;174(10):1349-1356. doi: 10.7326/M20-5415. Epub 2021 Aug 3.
citation: Raj SR, Faris PD, McRae M, Sheldon RS. Rationale for the prevention of syncope trial IV: assessment of midodrine. Clin Auton Res. 2012 Dec;22(6):275-80. doi: 10.1007/s10286-012-0167-5. Epub 2012 May 19.