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

Phase 4

Active, not recruiting

• Conditions: Vasovagal Syncope
• Interventions: Drug: midodrine hydrochloride; Drug: matching placebo

• Registration Number: NCT01456481
• Lead Sponsor: Dr. Bob Sheldon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Study Start: 2011-11
• Primary Completion: 2018-12-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midodrine hydrochloride pills	midodrine hydrochloride	-
oral placebo or sugar pill	midodrine hydrochloride	-
oral placebo or sugar pill	matching placebo	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the proportion of patients having at least one syncope recurrence.	1 year.

Secondary Outcome Measures

Name	Time	Method
A secondary outcome will be the time between the first and second syncope recurrences.	1 year
A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).	1 year.
A secondary outcome will be the frequency of syncopal spells.	1 year
A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.	1 year

Trial Locations

Locations (17)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Alberta Health Services - Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Red Deer Regional Hospital; 🇨🇦 Red Deer, Alberta, Canada

Victoria Cardiac Arrythmia Trials; 🇨🇦 Victoria, British Columbia, Canada

St. Boniface General Hospital; 🇨🇦 St. Boniface, Manitoba, Canada

New Brunswick Heart Centre; 🇨🇦 Saint John, New Brunswick, Canada

Queen E II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

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