Syncope, Vasovagal, Neurally-MediatedPhase 4NCT00118482
Clinical Trial for the Prevention of Vasovagal Syncope
A Phase 4 study testing fludrocortisone acetate in people with Syncope, Vasovagal, Neurally-Mediated, run by University of Calgary at 14 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Syncope, Vasovagal, Neurally-Mediated
- What is being tested?
- fludrocortisone acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 14 sitesin 2 countries
- Study dates
- May 2005to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Canada11 sites
University of Calgary, Faculty of Medicine
Calgary, Alberta, T2N 4N1
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Queen Elizabeth II, Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
McMaster University, Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Queen's University
Kingston, Ontario, K7V 2V7
University of Western Ontario, London Health Sciences
London, Ontario, N6A 5A5
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8
Hopital Sacre Coeur de Montreal
Montreal, Quebec, H4J 1C5
University of Ottawa, Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
United States3 sites
Boston University
Boston, Massachusetts, 02118
Vanderbilt University
Nashville, Tennessee, 37232-2195
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225-3838
About this study
Official title: 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.
Read the 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.
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Being tested
- fludrocortisone acetate
- Keywords
- vasovagal syncope, randomized clinical trial, quality of life
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludrocortisone acetateDrug
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
| Study group | Role | What they receive |
|---|---|---|
| fludrocortisone acetate | Experimental | Not described Receives: Drug: fludrocortisone acetate |
| Placebo | Placebo comparator | Not described Receives: Drug: fludrocortisone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months
Secondary outcomes (3)
The Frequency of Syncope Will be the First Secondary Outcome Measure.
Frequency will be reported as 12- month syncope event rates (%)
Measured: Within 12 months
Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.
Measured: 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.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Syncope, Vasovagal, Neurally-MediatedStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Bob Sheldon, University of Calgary
- Investigators
- Robert S. Sheldon, MD PhD, Principal investigator, University of Calgary, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118482
- Sponsor's protocol ID
- 130312
- Other IDs
- ISRCTN51802652
- Status last verified
- Sep 2019
- First submitted
- 30 Jun 2005
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tan VH, Ritchie D, Maxey C, Sheldon R; POST Investigators. Prospective Assessment of the Risk of Vasovagal Syncope During Driving. JACC Clin Electrophysiol. 2016 Apr;2(2):203-208. doi: 10.1016/j.jacep.2015.10.006. Epub 2015 Nov 17.
PubMed 29766871Sheldon R, Raj SR, Rose MS, Morillo CA, Krahn AD, Medina E, Talajic M, Kus T, Seifer CM, Lelonek M, Klingenheben T, Parkash R, Ritchie D, McRae M; POST 2 Investigators. Fludrocortisone for the Prevention of Vasovagal Syncope: A Randomized, Placebo-Controlled Trial. J Am Coll Cardiol. 2016 Jul 5;68(1):1-9. doi: 10.1016/j.jacc.2016.04.030.
PubMed 27364043Raj SR, Rose S, Ritchie D, Sheldon RS; POST II Investigators. The Second Prevention of Syncope Trial (POST II)--a randomized clinical trial of fludrocortisone for the prevention of neurally mediated syncope: rationale and study design. Am Heart J. 2006 Jun;151(6):1186.e11-7. doi: 10.1016/j.ahj.2006.03.013.
PubMed 16781217
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)
- ClinicalTrials.gov ID
- NCT00118482
- Acronym / sponsor ID
- 130312
- Conditions
- Syncope, Vasovagal, Neurally-Mediated
- Keywords
- vasovagal syncope, randomized clinical trial, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fludrocortisone acetate | Experimental | Drug: fludrocortisone acetate |
| Placebo | Placebo comparator | Drug: fludrocortisone acetate |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fludrocortisone acetateFludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily | Drug | Placebo, fludrocortisone acetate |
Primary outcome
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.
3 secondary outcomes
The Frequency of Syncope Will be the First Secondary Outcome Measure.
Time frame: Within 12 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29766871Tan VH, Ritchie D, Maxey C, Sheldon R; POST Investigators. Prospective Assessment of the Risk of Vasovagal Syncope During Driving. JACC Clin Electrophysiol. 2016 Apr;2(2):203-208. doi: 10.1016/j.jacep.2015.10.006. Epub 2015 Nov 17.
- Derived from this study: PubMed 27364043Sheldon R, Raj SR, Rose MS, Morillo CA, Krahn AD, Medina E, Talajic M, Kus T, Seifer CM, Lelonek M, Klingenheben T, Parkash R, Ritchie D, McRae M; POST 2 Investigators. Fludrocortisone for the Prevention of Vasovagal Syncope: A Randomized, Placebo-Controlled Trial. J Am Coll Cardiol. 2016 Jul 5;68(1):1-9. doi: 10.1016/j.jacc.2016.04.030.
- Derived from this study: PubMed 16781217Raj SR, Rose S, Ritchie D, Sheldon RS; POST II Investigators. The Second Prevention of Syncope Trial (POST II)--a randomized clinical trial of fludrocortisone for the prevention of neurally mediated syncope: rationale and study design. Am Heart J. 2006 Jun;151(6):1186.e11-7. doi: 10.1016/j.ahj.2006.03.013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. Sheldon, MD PhD principal investigator
University of Calgary, Faculty of Medicine
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fludrocortisone acetate in people with Syncope, Vasovagal, Neurally-Mediated, run by University of Calgary at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period. (time frame: Within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00118482, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.