NCT02500732

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

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

July 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

July 13, 2015

Results QC Date

March 24, 2020

Last Update Submit

April 20, 2020

Conditions

Vasovagal Syncope

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia

    1 hour post start of head up tilt

Secondary Outcomes (4)

  • Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia

    1 hour post start of head up tilt

  • Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope

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

  • Cardiac Index (From the Continuous BP Monitor) During Presyncope

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

  • Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule to be given the night before the study tilt, and the morning of the study tilt test.

Drug: Placebo

Atomoxetine

ACTIVE COMPARATOR

Atomoxetine 40mg PO to be given the night before the study tilt, and the morning of the study tilt test.

Drug: Atomoxetine

Interventions

AtomoxetineDRUG

40mg PO the night before and the morning of the study tilt table test.

Also known as: Strattera
Atomoxetine
PlaceboDRUG

oral placebo capsule designed to blind the atomoxetine intervention

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Syncope, Vasovagal

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title
Dr. Satish R Raj
Organization
University of Calgary
satish.raj@ucalgary.ca
403-210-6152

Study Officials

  • Satish R Raj, MD MSCI

    University of Calgary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study drug was encapsulated in opaque capsules by study personnel not involved in the day to day operations of the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

April 21, 2020

Results First Posted

April 21, 2020

Record last verified: 2020-04

Locations

CA(1)