Clinical Trial for the Prevention of Vasovagal Syncope

Syncope, Vasovagal, Neurally-Mediated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118482
• Other study ID #: 130312
• Secondary ID: ISRCTN51802652
• Status: Completed
• Phase: Phase 4
• Start date: May 2005
• Est. completion date: July 2011

Study information

• Verified date: September 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal
• Syncope, Vasovagal, Neurally-Mediated

Intervention

Drug:
• fludrocortisone acetate
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Calgary, Faculty of Medicine	Calgary	Alberta
Canada	Queen Elizabeth II, Halifax Infirmary	Halifax	Nova Scotia
Canada	McMaster University, Hamilton Health Sciences	Hamilton	Ontario
Canada	Queen's University	Kingston	Ontario
Canada	University of Western Ontario, London Health Sciences	London	Ontario
Canada	Hopital Sacre Coeur de Montreal	Montreal	Quebec
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	University of Ottawa, Ottawa Heart Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Boston University	Boston	Massachusetts
United States	Vanderbilt University	Nashville	Tennessee
United States	Virginia Cardiovascular Specialists	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.	This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.	Within 12 months
Secondary	The Frequency of Syncope Will be the First Secondary Outcome Measure.	Frequency will be reported as 12- month syncope event rates (%)	Within 12 months
Secondary	Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.		Within 12 months
Secondary	Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.	Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in patients on fludrocortisone vs placebo. Reported as RAND36 (Research ANd Development) score. The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Min value = 0 , Maximum value = 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	12 months