A randomised clinical trial of fludrocortisone for the prevention of vasovagal syncope
| ISRCTN | ISRCTN51802652 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51802652 |
| ClinicalTrials.gov (NCT) | NCT00118482 |
| Protocol serial number | 130312 |
| Sponsor | University of Calgary (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 130312) |
- Submission date
- 04/11/2004
- Registration date
- 23/06/2005
- Last edited
- 14/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Stanley Sheldon
Scientific
Scientific
Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary, Alberta
T2N 4N1
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised clinical trial of fludrocortisone for the prevention of vasovagal syncope |
| Study acronym | POST II |
| Study objectives | Fludrocortisone prevents recurrences of vasovagal syncope. |
| Ethics approval(s) | Yes, November 2004, October 2005 and October 2006 |
| Health condition(s) or problem(s) studied | Vasovagal syncope |
| Intervention | Double-blind, placebo-controlled trial of fludrocortisone. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fludrocortisone |
| Primary outcome measure(s) |
Time to first recurrence of syncope |
| Key secondary outcome measure(s) |
1. The frequency of syncope |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 310 |
| Key inclusion criteria | Children (greater than 13 years) and adults, either sex, with greater than two lifetime episodes of vasovagal syncope. |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Calgary
Calgary, Alberta
T2N 4N1
Canada
T2N 4N1
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/07/2016 | 14/02/2019 | Yes | No |
| Protocol article | protocol | 01/06/2006 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2019: Publication reference added.
