Condition category
Signs and Symptoms
Date applied
04/11/2004
Date assigned
23/06/2005
Last edited
18/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.faintingresearch.ca

Contact information

Type

Scientific

Primary contact

Dr Robert Stanley Sheldon

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00118482

Protocol/serial number

130312

Study information

Scientific title

Acronym

POST II

Study hypothesis

Fludrocortisone prevents recurrences of vasovagal syncope.

Ethics approval

Yes, November, 2004, October 2005 and October 2006

Study design

Double-blind, placebo-controlled trial of fludrocortisone.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Patient information can be found on the website at http://www.faintingresearch.ca/

Condition

Vasovagal syncope

Intervention

Double-blind, placebo-controlled trial of fludrocortisone.

Intervention type

Drug

Phase

Not Specified

Drug names

Fludrocortisone

Primary outcome measures

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 trial start date

01/06/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Children (greater than 13 years) and adults, either sex, with greater than two lifetime episodes of vasovagal syncope.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

310

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

Locations

Countries of recruitment

Canada

Trial participating centre

Faculty of Medicine
Calgary, Alberta
T2N 4N1
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

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

Sponsor type

University/education

Website

http://www.ucalgary.ca/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16781217

Publication citations

  1. Protocol

    Raj SR, Rose S, Ritchie D, Sheldon RS, , 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, 151, 6, 1186.e11-7, doi: 10.1016/j.ahj.2006.03.013.

Additional files

Editorial Notes