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Clinical Trial for the Prevention of Vasovagal Syncope

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ClinicalTrials.gov Identifier: NCT00118482
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
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
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
Hide 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
Arm/Group Title Fludrocortisone Acetate Placebo Total
Hide 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
Hide 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
1.Primary Outcome
Title The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludrocortisone Acetate Placebo
Hide 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.
Hide Description Frequency will be reported as 12- month syncope event rates (%)
Time Frame Within 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludrocortisone Acetate Placebo
Hide 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.
Hide Description [Not Specified]
Time Frame Within 12 months
Outcome Measure Data Not Reported
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.
Hide 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
Time Frame 12 months
Outcome Measure Data Not Reported
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
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fludrocortisone Acetate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/105 (0.00%)   0/105 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Responsible Party: Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier: NCT00118482     History of Changes
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: June 28, 2017