Clinical Trial for the Prevention of Vasovagal Syncope

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier:
NCT00118482
First received: June 30, 2005
Last updated: December 5, 2013
Last verified: December 2013

June 30, 2005
December 5, 2013
May 2005
July 2011   (final data collection date for primary outcome measure)
The primary outcome measure will be the time to the first recurrence of syncope. [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
The primary outcome measure will be the time to the first recurrence of syncope.
Complete list of historical versions of study NCT00118482 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Clinical Trial for the Prevention of Vasovagal Syncope
A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Syncope, Vasovagal, Neurally-Mediated
Drug: fludrocortisone acetate
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
  • Experimental: fludrocortisone acetate
    Intervention: Drug: fludrocortisone acetate
  • Placebo Comparator: Placebo
    Intervention: Drug: fludrocortisone acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00118482
130312, ISRCTN51802652
Yes
Dr. Bob Sheldon, University of Calgary
University of Calgary
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Robert S. Sheldon, MD PhD University of Calgary, Faculty of Medicine
University of Calgary
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP