Clinical trial

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

Name

CIHR#243314

Description

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.

Trial arms

Trial start

2011-11-01

Estimated PCD

2018-12-20

Trial end

2024-12-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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.

Arms:

midodrine hydrochloride pills, oral placebo or sugar pill

Other names:

Brand name for the drug is midodrine.

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.

Arms:

oral placebo or sugar pill

Size

134

Primary endpoint

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

1 year.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 134, 'type': 'ACTUAL'}}

Updated at

2024-05-09

1 organization

2 products

1 indication

Organization

Product

Indication

Product