Clinical Trial for the Prevention of Vasovagal Syncope
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00118482 |
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Recruitment Status :
Completed
First Posted : July 11, 2005
Results First Posted : June 28, 2017
Last Update Posted : October 15, 2019
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Syncope, Vasovagal, Neurally-Mediated | Drug: fludrocortisone acetate | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 213 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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) |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | July 2011 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period. [ Time Frame: Within 12 months ]This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.
- The Frequency of Syncope Will be the First Secondary Outcome Measure. [ Time Frame: Within 12 months ]Frequency will be reported as 12- month syncope event rates (%)
- Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score. [ Time Frame: Within 12 months ]
- 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 ]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.
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| Ages Eligible for Study: | 14 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118482
| 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 | |
| Institut de Cardiologie de Montreal | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Hopital Sacre Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Principal Investigator: | Robert S. Sheldon, MD PhD | University of Calgary, Faculty of Medicine |
| Responsible Party: | Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00118482 |
| Other Study ID Numbers: |
130312 ISRCTN51802652 |
| First Posted: | July 11, 2005 Key Record Dates |
| Results First Posted: | June 28, 2017 |
| Last Update Posted: | October 15, 2019 |
| Last Verified: | September 2019 |
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vasovagal syncope randomized clinical trial quality of life |
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Syncope Syncope, Vasovagal Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Fludrocortisone Anti-Inflammatory Agents |