Trial Outcomes & Findings for Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope (NCT NCT02500732)

NCT ID: NCT02500732

Last Updated: 2020-04-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 57 participants
• Primary outcome timeframe: 1 hour post start of head up tilt
• Results posted on: 2020-04-21

Participant Flow

Participant milestones

Measure	Placebo Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Overall Study STARTED	27	30
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Placebo Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Overall Study Physician Decision	0	1

Baseline Characteristics

Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope

Baseline characteristics by cohort

Measure	Placebo n=27 Participants Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine n=29 Participants Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.	Total n=56 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 14 • n=5 Participants	35 years STANDARD_DEVIATION 14 • n=7 Participants	35 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Calgary Syncope Symptom Score (CSSS)	3 units on a scale n=5 Participants	3 units on a scale n=7 Participants	3 units on a scale n=5 Participants
Lifetime Syncope Spells	11 events n=5 Participants	12 events n=7 Participants	12 events n=5 Participants
Syncopal Spells in Previous Year	3 events n=5 Participants	3 events n=7 Participants	3 events n=5 Participants

PRIMARY outcome

Timeframe: 1 hour post start of head up tilt

Outcome measures

Measure	Placebo n=27 Participants Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine n=29 Participants Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia	19 Participants	10 Participants

SECONDARY outcome

Timeframe: 1 hour post start of head up tilt

Outcome measures

Measure	Placebo n=27 Participants Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine n=29 Participants Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia	2 Participants	13 Participants

SECONDARY outcome

Timeframe: From baseline to within 1 hour post start of head up tilt

Outcome measures

Measure	Placebo n=27 Participants Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine n=29 Participants Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope	20 mL/m2 Standard Deviation 12	27 mL/m2 Standard Deviation 6

SECONDARY outcome

Timeframe: From baseline to within 1 hour post start of head up tilt

Outcome measures

Measure	Placebo n=27 Participants Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine n=29 Participants Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Cardiac Index (From the Continuous BP Monitor) During Presyncope	1.34 L/min/m2 Standard Deviation 0.29	2.73 L/min/m2 Standard Deviation 1.10

SECONDARY outcome

Timeframe: From baseline to within 1 hour post start of head up tilt

Outcome measures

Measure	Placebo n=27 Participants Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test. Placebo: oral placebo capsule designed to blind the atomoxetine intervention	Atomoxetine n=29 Participants Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test. Atomoxetine: 40mg PO the night before and the morning of the study tilt table test.
Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope	2183 dynes*s/cm5*m2 Standard Deviation 1238	2034 dynes*s/cm5*m2 Standard Deviation 525

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atomoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Satish R Raj

University of Calgary

Phone: 403-210-6152

Email: satish.raj@ucalgary.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place