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Clinical Trial for the Prevention of Vasovagal Syncope

NCT00118482 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2019-10-15

Study results available
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Summary

The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo.

Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.

Conditions

  • Syncope, Vasovagal, Neurally-Mediated

Interventions

DRUG

fludrocortisone acetate

Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Calgary

    lead OTHER

Principal Investigators

  • Robert S. Sheldon, MD PhD · University of Calgary, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118482 on ClinicalTrials.gov