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Clinical Trial for the Prevention of Vasovagal Syncope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118482
First Posted: July 11, 2005
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary
Results First Submitted: October 26, 2016  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between October 1998 and April 2003 from university hospitals in Canada, Columbia, the United States and Poland.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fludrocortisone Acetate fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Placebo fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily

Participant Flow:   Overall Study
    Fludrocortisone Acetate   Placebo
STARTED   105 [1]   105 
COMPLETED   75 [2]   76 
NOT COMPLETED   30   29 
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Median age was 30.5 years and 146 were women.

Reporting Groups
  Description
Fludrocortisone Acetate fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Placebo fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Total Total of all reporting groups

Baseline Measures
   Fludrocortisone Acetate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 105   105   210 
Age 
[Units: Years]
Median (Standard Deviation)
 28  (11.5)   31  (12)   30.5  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      71  67.6%      75  71.4%      146  69.5% 
Male      34  32.4%      30  28.6%      64  30.5% 
Region of Enrollment 
[Units: Participants]
     
United States   8   8   16 
Canada   85   85   170 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.   [ Time Frame: Within 12 months ]

2.  Secondary:   The Frequency of Syncope Will be the First Secondary Outcome Measure.   [ Time Frame: Within 12 months ]

3.  Secondary:   Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.   [ Time Frame: Within 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: sheldon@ucalgary.ca


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

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