Clinical Trial for the Prevention of Vasovagal Syncope - Full Text View

Sponsor:	University of Calgary
Collaborator:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)

Resource links provided by NLM:

MedlinePlus related topics: Fainting

Drug Information available for: Fludrocortisone Fludrocortisone 21-acetate

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

The primary outcome measure will be the time to the first recurrence of syncope. [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The frequency of syncope will be the first secondary outcome measure. [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
Presyncope frequency, duration, and intensity will be the second secondary outcome measures, both alone and in a composite score. [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in treated and untreated patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	310
Study Start Date:	May 2005
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: fludrocortisone acetate	Drug: fludrocortisone acetate Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Placebo Comparator: Placebo	Drug: fludrocortisone acetate Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118482

Locations

United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2195
United States, Virginia
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23225-3838
Canada, Alberta
University of Calgary, Faculty of Medicine
Calgary, Alberta, Canada, T2N 4N1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Queen Elizabeth II, Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
McMaster University, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Queen's University
Kingston, Ontario, Canada, K7V 2V7
University of Western Ontario, London Health Sciences
London, Ontario, Canada, N6A 5A5
University of Ottawa, Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Hopital Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

University of Calgary

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Robert S. Sheldon, MD PhD

University of Calgary, Faculty of Medicine

More Information

No publications provided

Responsible Party:	Dr. Robert S. Sheldon, University of Calgary
ClinicalTrials.gov Identifier:	NCT00118482 History of Changes
Other Study ID Numbers:	130312, ISRCTN51802652
Study First Received:	June 30, 2005
Last Updated:	May 13, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by University of Calgary:

vasovagal syncope
randomized clinical trial
quality of life

Additional relevant MeSH terms:

Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Fludrocortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012