UnknownPhase 4

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

United States, Canada, Poland134 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year.

Trial details

NCT IDNCT01456481

SponsorDr. Bob Sheldon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-20

View on ClinicalTrials.gov More Vasovagal Syncope trials