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| Sponsors and Collaborators: |
University of Calgary Canadian Institutes of Health Research (CIHR) |
|---|---|
| Information provided by: | University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00118482 |
Purpose
The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo.
Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
| Condition | Intervention | Phase |
|---|---|---|
|
Syncope, Vasovagal, Neurally-Mediated |
Drug: fludrocortisone acetate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II) |
| Estimated Enrollment: | 310 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| fludrocortisone acetate: Experimental |
Drug: fludrocortisone acetate
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
|
| Placebo: Placebo Comparator |
Drug: fludrocortisone acetate
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
|
About 10% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, and have well-documented reduced quality of life. There are no therapies that have withstood the test of adequately conducted and credible randomized clinical trials. There is ample evidence of the importance of blood volume in the pathophysiology of vasovagal syncope.
Fludrocortisone acetate is a corticosteroid with a mild enhancement of glucocorticoid activity and a marked increase in mineralocorticoid activity. It has no appreciable glucocorticoid effect at doses between 0.05 to 0.2 mg, which are the commonly used clinical doses for various disorders requiring mineralocorticoid adrenal replacement. The acute actions of fludrocortisone acetate are sodium and water retention, at the expense of urinary potassium excretion. Blood volume expansion with either dietary salt supplementation or fludrocortisone is often recommended by clinicians for the treatment of vasovagal syncope despite a paucity of good evidence for their efficacy. Four clinical studies suggest its utility in the prevention of syncope. Fludrocortisone might decrease the incidence of vasovagal syncope, but the quality of the evidence supporting its use is poor. There are no randomized, placebo-controlled trials of fludrocortisone for the prevention of vasovagal syncope. In this 5-year study the investigators will test the hypothesis that fludrocortisone prevents recurrences of vasovagal syncope.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert S Sheldon, MD PhD | 403-220-8191 | sheldon@ucalgary.ca |
| United States, Massachusetts | |
| Boston University | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Paul Lelorier, MD 617-638-8954 | |
| Principal Investigator: Paul Lelorier, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232-2195 | |
| Contact: Satish Raj, MD 615-343-6499 | |
| Principal Investigator: Satish Raj, MD | |
| United States, Virginia | |
| Virginia Cardiovascular Specialists | Recruiting |
| Richmond, Virginia, United States, 23225-3838 | |
| Contact: David Gilligan, MD 804-323-5011 | |
| Principal Investigator: David Gilligan, MD | |
| Canada, Alberta | |
| University of Calgary, Faculty of Medicine | Recruiting |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Contact: Robert S. Sheldon, MD PhD 403-220-8191 sheldon@ucalgary.ca | |
| Principal Investigator: Robert S. Sheldon, MD PhD | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Michael Giuffre, MD 403-955-7211 | |
| Principal Investigator: Michael Giuffre, MD | |
| Canada, Manitoba | |
| St. Boniface General Hospital | Recruiting |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Contact: Colette Seiffer, MD | |
| Principal Investigator: Colette Seiffer, MD | |
| Canada, Nova Scotia | |
| Queen Elizabeth II, Halifax Infirmary | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Contact: Ratika Parkash, MD 902-473-4474 | |
| Principal Investigator: Ratika Parkash, MD | |
| Canada, Ontario | |
| University of Western Ontario, London Health Sciences | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Contact: Andrew Krahn, MD 519-685-8300 | |
| Principal Investigator: Andrew Krahn, MD | |
| McMaster University, Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Contact: Carlos Morillo, MD 905-527-4322 | |
| Principal Investigator: Carlos Morillo, MD | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Paul Dorion, MD 416-864-5104 | |
| Principal Investigator: Paul Dorion, MD | |
| University of Ottawa, Ottawa Heart Institute | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Contact: David Birnie, MD 613-798-5555 | |
| Principal Investigator: David Birnie, MD | |
| Queen's University | Recruiting |
| Kingston, Ontario, Canada, K7V 2V7 | |
| Contact: Adrian Baranchuk, MD 613-549-6666 | |
| Principal Investigator: Adrian Baranchuk, MD | |
| Canada, Quebec | |
| Institut de Cardiologie de Montreal | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Mario Talajic, MD 514-376-3330 | |
| Principal Investigator: Mario Talajic, MD | |
| Hopital Sacre Coeur de Montreal | Recruiting |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Contact: Theresa Kus, MD 514-338-2650 | |
| Principal Investigator: Theresa Kus, MD | |
| Principal Investigator: | Robert S. Sheldon, MD PhD | University of Calgary, Faculty of Medicine |
More Information
| Responsible Party: | University of Calgary ( Dr. Robert S. Sheldon ) |
| Study ID Numbers: | 130312, ISRCTN51802652 |
| Study First Received: | June 30, 2005 |
| Last Updated: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00118482 History of Changes |
| Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
|
vasovagal syncope randomized clinical trial quality of life |
|
Anti-Inflammatory Agents Signs and Symptoms Unconsciousness Consciousness Disorders Quality of Life |
Neurologic Manifestations Fludrocortisone Neurobehavioral Manifestations Syncope Syncope, Vasovagal |
|
Anti-Inflammatory Agents Signs and Symptoms Unconsciousness Therapeutic Uses Nervous System Diseases Consciousness Disorders |
Neurologic Manifestations Fludrocortisone Neurobehavioral Manifestations Syncope Pharmacologic Actions Syncope, Vasovagal |
