Trial Outcomes & Findings for Clinical Trial for the Prevention of Vasovagal Syncope (NCT NCT00118482)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

213 participants

Primary outcome timeframe

Within 12 months

Results posted on

2019-10-15

Participant Flow

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	105	105
Overall Study COMPLETED	75	76
Overall Study NOT COMPLETED	30	29

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	7	7
Overall Study Withdrawal by Subject	23	22

Baseline Characteristics

Clinical Trial for the Prevention of Vasovagal Syncope

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fludrocortisone Acetate n=105 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Placebo n=105 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Total n=210 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 11.5 • n=5 Participants	31 years STANDARD_DEVIATION 12 • n=7 Participants	30.5 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	75 Participants n=7 Participants	146 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Canada	85 participants n=5 Participants	85 participants n=7 Participants	170 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 12 months

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

Outcome measures

Outcome measures
Measure	Fludrocortisone Acetate n=105 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Placebo n=105 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.	42 Participants	54 Participants

SECONDARY outcome

Timeframe: Within 12 months

Frequency will be reported as 12- month syncope event rates (%)

Outcome measures

Outcome measures
Measure	Fludrocortisone Acetate n=105 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Placebo n=105 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
The Frequency of Syncope Will be the First Secondary Outcome Measure.	44.0 rate % Interval 42.0 to 94.0	60.5 rate % Interval 46.0 to 103.0

SECONDARY outcome

Timeframe: Within 12 months

Population: Data not analyzed because of variability of data collected on presyncope

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Fludrocortisone Acetate n=76 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Placebo n=85 Participants fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.	69 score on a scale Standard Deviation 21	84 score on a scale Standard Deviation 11

Adverse Events

Fludrocortisone Acetate

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fludrocortisone Acetate n=105 participants at risk fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily	Placebo n=105 participants at risk fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
General disorders Headache	7.6% 8/105 • Adverse event data were collected for the length of each participant's time in the trial up to 1 year.	7.6% 8/105 • Adverse event data were collected for the length of each participant's time in the trial up to 1 year.

Additional Information

Dr. Robert S. Sheldon

University of Calgary

Phone: 403-2208191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place