Clinical Trial for the Prevention of Vasovagal Syncope

• ClinicalTrials.gov Identifier: NCT00118482
• Recruitment Status: Completed
• First Posted: July 11, 2005
• Results First Posted: June 28, 2017
• Last Update Posted: October 15, 2019
• Sponsor: University of Calgary
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Dr. Bob Sheldon, University of Calgary

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Syncope, Vasovagal, Neurally-Mediated
• Intervention: Drug: fludrocortisone acetate
• Enrollment: 213

Participant Flow

Recruitment Details	Patients were recruited between October 1998 and April 2003 from university hospitals in Canada, Columbia, the United States and Poland.
Pre-assignment Details

Arm/Group Title	Fludrocortisone Acetate	Placebo
Arm/Group Description	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Period Title: Overall Study
Started	105 [1]	105
Completed	75 [2]	76
Not Completed	30	29
Reason Not Completed
Lost to Follow-up	7	7
Withdrawal by Subject	23	22
[1] 3 patients signed the consent but did not take the study medication.; [2] 210 in the Intention To Treat analysis

Baseline Characteristics

Arm/Group Title		Fludrocortisone Acetate	Placebo	Total
Arm/Group Description		fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Total of all reporting groups
Overall Number of Baseline Participants		105	105	210
Baseline Analysis Population Description		Median age was 30.5 years and 146 were women.
Age, Continuous; Median (Standard Deviation); Unit of measure: Years
	Number Analyzed	105 participants	105 participants	210 participants
		28 (11.5)	31 (12)	30.5 (12)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	105 participants	105 participants	210 participants
	Female	71 67.6%	75 71.4%	146 69.5%
	Male	34 32.4%	30 28.6%	64 30.5%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	105 participants	105 participants	210 participants
United States		8	8	16
Canada		85	85	170

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.
Description	This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.
Time Frame	Within 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fludrocortisone Acetate	Placebo
Arm/Group Description:	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Overall Number of Participants Analyzed	105	105
Measure Type: Count of Participants; Unit of Measure: Participants
	42 40.0%	54 51.4%

2. Secondary Outcome

Title	The Frequency of Syncope Will be the First Secondary Outcome Measure.
Description	Frequency will be reported as 12- month syncope event rates (%)
Time Frame	Within 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fludrocortisone Acetate	Placebo
Arm/Group Description:	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Overall Number of Participants Analyzed	105	105
Mean (95% Confidence Interval); Unit of Measure: rate %
	44.0; (42 to 94)	60.5; (46 to 103)

3. Secondary Outcome

Title	Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.
Description	[Not Specified]
Time Frame	Within 12 months

Outcome Measure Data

Analysis Population Description

Data not analyzed because of variability of data collected on presyncope

Arm/Group Title	Fludrocortisone Acetate	Placebo
Arm/Group Description:	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fludrocortisone Acetate	Placebo
Arm/Group Description:	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Overall Number of Participants Analyzed	76	85
Mean (Standard Deviation); Unit of Measure: score on a scale
	69 (21)	84 (11)

Adverse Events

Time Frame	Adverse event data were collected for the length of each participant's time in the trial up to 1 year.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Fludrocortisone Acetate	Placebo
Arm/Group Description	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
All-Cause Mortality
	Fludrocortisone Acetate	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Fludrocortisone Acetate	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/105 (0.00%)	0/105 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Fludrocortisone Acetate	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/105 (7.62%)	8/105 (7.62%)
General disorders
Headache	8/105 (7.62%)	8/105 (7.62%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Robert S. Sheldon
• Organization: University of Calgary
• Phone: 403-2208191
• EMail: sheldon@ucalgary.ca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sheldon 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.

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.

Raj 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.

• Responsible Party: Dr. Bob Sheldon, University of Calgary
• ClinicalTrials.gov Identifier: NCT00118482
• Other Study ID Numbers: 130312; ISRCTN51802652
• First Submitted: June 30, 2005
• First Posted: July 11, 2005
• Results First Submitted: October 26, 2016
• Results First Posted: June 28, 2017
• Last Update Posted: October 15, 2019