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

NCT ID: NCT01456481

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2024-12-31

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.

Conditions

Vasovagal Syncope

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

midodrine hydrochloride pills

Group Type: ACTIVE_COMPARATOR

midodrine hydrochloride

Intervention Type: DRUG

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.

oral placebo or sugar pill

Group Type: PLACEBO_COMPARATOR

midodrine hydrochloride

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Brand name for the drug is midodrine.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

Dr. Bob Sheldon

OTHER

Sponsor Role: lead

Responsible Party

Dr. Bob Sheldon

Professor of Cardiac Sciences, Medicine and Medical Genetics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Hamilton Health Sciences

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Hopital Sacre Coeur de Montreal

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Prairie Vascular Research Network/Regina General Hospital

Regina, Saskatchewan, Canada

Saskatoon Cardiology Consultants/Royal University Hospital

Saskatoon, Saskatchewan, Canada

Medical University of Lodz

Lodz, , Poland

Countries

United States; Canada; Poland

References

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.

Reference Type: DERIVED

PMID: 34339231 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22610268 (View on PubMed)

Other Identifiers

CIHR#243314

Identifier Type: -

Identifier Source: org_study_id