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

Vasovagal Syncope Clinical Trial

— POST 4  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01456481
• Other study ID #: CIHR#243314
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 134
• Est. completion date: December 31, 2024
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal
• Vasovagal Syncope

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Alberta Health Services - Royal Alexandra Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Queen E II Health Sciences Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Hopital Sacre Coeur de Montreal	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Red Deer Regional Hospital	Red Deer	Alberta
Canada	Prairie Vascular Research Network/Regina General Hospital	Regina	Saskatchewan
Canada	New Brunswick Heart Centre	Saint John	New Brunswick
Canada	Saskatoon Cardiology Consultants/Royal University Hospital	Saskatoon	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	St. Boniface General Hospital	St. Boniface	Manitoba
Canada	Victoria Cardiac Arrythmia Trials	Victoria	British Columbia
Poland	Medical University of Lodz	Lodz
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Bob Sheldon	Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the proportion of patients having at least one syncope recurrence.		1 year.
Secondary	A secondary outcome will be the time between the first and second syncope recurrences.		1 year
Secondary	A secondary outcome will be the frequency of syncopal spells.		1 year
Secondary	A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).		1 year.
Secondary	A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.		1 year