Phase 2 N=57 Randomized Quadruple-blind Treatment

Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope

Vasovagal Syncope

Bottom Line

View on ClinicalTrials.gov: NCT02500732 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia — 19; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atomoxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Calgary
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia	19; 10	—
SECONDARY Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia	2; 13	—
SECONDARY Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope	20; 27	—
SECONDARY Cardiac Index (From the Continuous BP Monitor) During Presyncope	1.34; 2.73	—
SECONDARY Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope	2183; 2034	—

Summary

Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.

Eligibility Criteria

Inclusion Criteria

1 or more syncopal spells in the year preceding enrolment
More than -2 points on the Calgary Syncope Symptom Score
Age ≥18 years with informed consent

Exclusion Criteria

Other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome
Inability to give informed consent
important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia.
hypertrophic cardiomyopathy
a permanent pacemaker
a seizure disorder
hypertension defined as >150/90 mm Hg
pregnancy
glaucoma
medications with known effects on blood pressure
Known hypersensitivity to atomoxetine and derivatives

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02500732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.