NCT00118482

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Longer than P75 for phase_4

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

October 15, 2019

Status Verified

September 1, 2019

Enrollment Period

6.2 years

First QC Date

June 30, 2005

Results QC Date

October 26, 2016

Last Update Submit

September 24, 2019

Conditions

Syncope, Vasovagal, Neurally-Mediated

Keywords

vasovagal syncoperandomized clinical trialquality of life

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.

    This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.

    Within 12 months

Secondary Outcomes (3)

  • The Frequency of Syncope Will be the First Secondary Outcome Measure.

    Within 12 months

  • Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.

    Within 12 months

  • Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.

    12 months

Study Arms (2)

fludrocortisone acetate

EXPERIMENTAL
Drug: fludrocortisone acetate

Placebo

PLACEBO COMPARATOR
Drug: fludrocortisone acetate

Interventions

fludrocortisone acetateDRUG

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

Placebofludrocortisone acetate

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Syncope as a cause of loss of consciousness according to European Society of Cardiology criteria
  • \> 2 lifetime syncopal spells preceding enrollment
  • \> or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts
  • Age \> 18 years with informed consent, or age \> 14 years with consent and informed parental consent

You may not qualify if:

  • Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome
  • An inability to give informed consent
  • Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia
  • Hypertrophic cardiomyopathy
  • A known intolerance to fludrocortisone
  • Another clinical need for fludrocortisone that cannot be met with other drugs
  • A permanent pacemaker
  • A seizure disorder
  • A major chronic non cardiovascular disease
  • Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure
  • Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m2 according to the Cockroft-Gault formula)
  • Diabetes mellitus
  • Hepatic disease
  • Glaucoma
  • Any prior use of fludrocortisone acetate
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Boston University

Boston, Massachusetts, 02118, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-2195, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23225-3838, United States

Location

University of Calgary, Faculty of Medicine

Calgary, Alberta, T2N 4N1, Canada

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Queen Elizabeth II, Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

McMaster University, Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Queen's University

Kingston, Ontario, K7V 2V7, Canada

Location

University of Western Ontario, London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa, Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

Hopital Sacre Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (3)

  • 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.

    PMID: 29766871DERIVED

  • 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.

    PMID: 27364043DERIVED

  • 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.

    PMID: 16781217DERIVED

MeSH Terms

Conditions

Syncope, Vasovagal

Interventions

fludrocortisone acetate

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Robert S. Sheldon
Organization
University of Calgary
sheldon@ucalgary.ca
403-2208191

Study Officials

  • Robert S. Sheldon, MD PhD

    University of Calgary, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiac Sciences, Medicine and Medical Genetics

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

May 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 15, 2019

Results First Posted

June 28, 2017

Record last verified: 2019-09

Locations

US(3)CA(11)