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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midodrine hydrochloride pills | Active Comparator |
| |
| oral placebo or sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midodrine hydrochloride | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be the proportion of patients having at least one syncope recurrence. | 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary outcome will be the time between the first and second syncope recurrences. | 1 year | |
| A secondary outcome will be the frequency of syncopal spells. | 1 year | |
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Inclusion Criteria:
Patients will be eligible if they have:
Exclusion Criteria:
Patients will be excluded if they have:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Vanderbilt University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34339231 | Derived | 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. | |
| 22610268 |
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|
|
| matching placebo | 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. |
|
| A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). |
| 1 year. |
| A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. | 1 year |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Alberta Health Services - Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Red Deer Regional Hospital | Red Deer | Alberta | T4N 4E7 | Canada |
| Victoria Cardiac Arrythmia Trials | Victoria | British Columbia | V8R 4R2 | Canada |
| St. Boniface General Hospital | St. Boniface | Manitoba | R2H 2A6 | Canada |
| New Brunswick Heart Centre | Saint John | New Brunswick | E2L 4L2 | Canada |
| Queen E II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A6 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Hopital Sacre Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Prairie Vascular Research Network/Regina General Hospital | Regina | Saskatchewan | S4P 0W5 | Canada |
| Saskatoon Cardiology Consultants/Royal University Hospital | Saskatoon | Saskatchewan | S7K 3H1 | Canada |
| Medical University of Lodz | Lodz | 93-005 | Poland |
| 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. |
| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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