Clinical Trial for the Prevention of Vasovagal Syncope

Condition(s) targeted: Syncope, Vasovagal, Neurally-Mediated

Intervention: fludrocortisone acetate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
Robert S. Sheldon, MD PhD, Principal Investigator, Affiliation: University of Calgary, Faculty of Medicine

Overall contact:
Robert S Sheldon, MD PhD, Phone: 403-220-8191, Email: sheldon@ucalgary.ca

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.

Official title: A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary outcome measure will be the time to the first recurrence of syncope.

Secondary outcome:

The frequency of syncope will be the first secondary outcome measure.

Presyncope frequency, duration, and intensity will be the second secondary outcome measures, both alone and in a composite score.

Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in treated and untreated patients.

Detailed description: 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.

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Syncope as a cause of loss of consciousness according to European Society of

Cardiology criteria

- > 2 lifetime syncopal spells preceding enrollment

- > or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts

- Age > 18 years with informed consent, or age > 14 years with consent and informed

parental consent

Exclusion Criteria:

- Other causes of syncope, such as ventricular tachycardia, complete heart block,

postural (orthostatic) 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 known intolerance to fludrocortisone

- Another clinical need for fludrocortisone that cannot be met with other drugs

- A permanent pacemaker

- A seizure disorder

- A major chronic non cardiovascular disease

- Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure

- Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1. 73m2

according to the Cockroft-Gault formula)

- Diabetes mellitus

- Hepatic disease

- Glaucoma

- Any prior use of fludrocortisone acetate

- A 5-minute stand test resulting in diagnosis of postural orthostatic tachycardia

syndrome or orthostatic hypotension

Robert S Sheldon, MD PhD, Phone: 403-220-8191, Email: sheldon@ucalgary.ca

University of Calgary, Faculty of Medicine, Calgary, Alberta T2N 4N1, Canada; Recruiting
Robert S. Sheldon, MD PhD, Phone: 403-220-8191, Email: sheldon@ucalgary.ca
Robert S. Sheldon, MD PhD, Principal Investigator

Alberta Children's Hospital, Calgary, Alberta T3B 6A8, Canada; Recruiting
Michael Giuffre, MD, Phone: 403-955-7211
Michael Giuffre, MD, Principal Investigator

St. Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada; Recruiting
Colette Seiffer, MD
Colette Seiffer, MD, Principal Investigator

Boston University, Boston, Massachusetts 02118, United States; Recruiting
Paul Lelorier, MD, Phone: 617-638-8954
Paul Lelorier, MD, Principal Investigator

Queen Elizabeth II, Halifax Infirmary, Halifax, Nova Scotia B3H 3A7, Canada; Recruiting
Ratika Parkash, MD, Phone: 902-473-4474
Ratika Parkash, MD, Principal Investigator

University of Western Ontario, London Health Sciences, London, Ontario N6A 5A5, Canada; Recruiting
Andrew Krahn, MD, Phone: 519-685-8300
Andrew Krahn, MD, Principal Investigator

McMaster University, Hamilton Health Sciences, Hamilton, Ontario L8L 2X2, Canada; Recruiting
Carlos Morillo, MD, Phone: 905-527-4322
Carlos Morillo, MD, Principal Investigator

St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Paul Dorion, MD, Phone: 416-864-5104
Paul Dorion, MD, Principal Investigator

University of Ottawa, Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada; Recruiting
David Birnie, MD, Phone: 613-798-5555
David Birnie, MD, Principal Investigator

Queen's University, Kingston, Ontario K7V 2V7, Canada; Recruiting
Adrian Baranchuk, MD, Phone: 613-549-6666
Adrian Baranchuk, MD, Principal Investigator

Institut de Cardiologie de Montreal, Montreal, Quebec H1T 1C8, Canada; Recruiting
Mario Talajic, MD, Phone: 514-376-3330
Mario Talajic, MD, Principal Investigator

Hopital Sacre Coeur de Montreal, Montreal, Quebec H4J 1C5, Canada; Recruiting
Theresa Kus, MD, Phone: 514-338-2650
Theresa Kus, MD, Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232-2195, United States; Recruiting
Satish Raj, MD, Phone: 615-343-6499
Satish Raj, MD, Principal Investigator

Virginia Cardiovascular Specialists, Richmond, Virginia 23225-3838, United States; Recruiting
David Gilligan, MD, Phone: 804-323-5011
David Gilligan, MD, Principal Investigator

Starting date: May 2005
Ending date: December 2010
Last updated: April 23, 2008