A randomised clinical trial of fludrocortisone for the prevention of vasovagal syncope

ISRCTN	ISRCTN51802652
DOI	https://doi.org/10.1186/ISRCTN51802652
ClinicalTrials.gov number	NCT00118482
Secondary identifying numbers	130312

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Robert Stanley Sheldon
Scientific

Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary, Alberta
T2N 4N1
Canada

Study design	Double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Patient information can be found on the website at http://www.faintingresearch.ca/
Scientific title	A randomised clinical trial of fludrocortisone for the prevention of vasovagal syncope
Study acronym	POST II
Study hypothesis	Fludrocortisone prevents recurrences of vasovagal syncope.
Ethics approval(s)	Yes, November 2004, October 2005 and October 2006
Condition	Vasovagal syncope
Intervention	Double-blind, placebo-controlled trial of fludrocortisone.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fludrocortisone
Primary outcome measure	Time to first recurrence of syncope
Secondary outcome measures	1. The frequency of syncope 2. Pre-syncope frequency duration and intensity 3. Quality of life
Overall study start date	01/06/2005
Overall study end date	31/12/2009

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	310
Participant inclusion criteria	Children (greater than 13 years) and adults, either sex, with greater than two lifetime episodes of vasovagal syncope.
Participant exclusion criteria	1. Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome 2. An inability to give informed consent 3. Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia 4. Hypertrophic cardiomyopathy 5. A known intolerance to fludrocortisone 6. Another clinical need for fludrocortisone that can not be met with other drugs 7. A permanent pacemaker 8. A seizure disorder 9. A major chronic non-cardiovascular disease 10. Hypertension (blood pressure more than or equal to 130/85 on two occasions) or heart failure 11. Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m^2 according to the Cockroft-Gault formula) 12. Diabetes mellitus 13. Hepatic disease 14. Glaucoma 15. Any prior use of fludrocortisone acetate 16. A five-minute stand test resulting in diagnosis of postural orthostatic tachycardia syndrome or orthostatic hypotension
Recruitment start date	01/06/2005
Recruitment end date	31/12/2009

University of Calgary

Calgary, Alberta
T2N 4N1
Canada

University of Calgary (Canada)
University/education

Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary, Alberta
T2N 4N1
Canada

Website	http://www.ucalgary.ca/
"ROR"	https://ror.org/03yjb2x39

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 130312)
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/06/2006		Yes	No
Results article	results	05/07/2016	14/02/2019	Yes	No

14/02/2019: Publication reference added.