Trial DesignsThe Seventh Prevention of Syncope Trial (POST VII)—A randomized clinical trial of atomoxetine for the prevention of vasovagal syncope: Rationale and study design
Section snippets
Background
Vasovagal syncope (VVS) is a common and difficult to treat problem. About 40% of people faint at least once in their life,1,2 and at least 20% of adults faint more than once. It is a frequent reason for visits to the primary care physician,3 and among presentation to the emergency department with syncope the final diagnosis in 43% of patients.4 In patients with VVS, quality of life is markedly impaired,5., 6., 7., 8. there is high anxiety,8 and a substantial risk of injury,9,10 all of which
Study aim
The primary hypothesis is that in patients with moderate to high risk of a recurrence of VVS, a decision to treat with atomoxetine will reduce the likelihood of a patient having at least one syncope recurrence, compared with placebo. The primary end point is the first syncope recurrence. The major secondary analyses will test whether atomoxetine will reduce syncope frequency, reduce the rate of patients with at least one recurrence, reduce health care utilization and cost, and improve quality
Study design
POST VII is a multicenter, randomized, double-blind, placebo-controlled, crossover study that began in July 2022. Patient enrollment is slated to conclude in 2026, and follow-up and data analysis are slated to conclude in 2027. Patients will be followed up for a minimum of 12 months (Figure).
Patients are eligible if they are ≥18 years of age, have a score of ≥-2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts,19 and have had ≥2 syncopal spells in the year preceding
Data analysis
The primary end point is the first syncope recurrence. A “syncope” spell will be defined according to the Heart Rhythm Society 2015 Scientific Statement23 and verified with a combination of patient recollection of the nature of the syncopal spell, collateral history from bystander witnesses, and by examination of the patient for signs of physical trauma such as abrasions, contusions, and fractures. Patients will be interviewed by the clinic nurse within 1 week of the syncopal spell. Outcomes
Funding
The Canadian Institute of Health Research under Award Number PJT-178-139 supports the research and creation of the paper. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.
Study registration
POST7 is registered with the with National Institutes of Health-sponsored ClinicalTrials.gov (www.clinicaltrials.gov), having study no. NCT05159687 on December 16, 2021.
Study organization
The Executive Committee will consist of Drs R.S. Sheldon, (University of Calgary, Calgary, Alberta, Canada), S.R. Raj (University of Calgary, Calgary, Alberta, Canada), C. Morillo (University of Calgary, Calgary, Alberta, Canada), G. Chen (University of Calgary, Calgary, Alberta, Canada), M. Runte (Patient Lead, University of Lethbridge, Alberta, Canada), and D. Chew (University of Calgary, Calgary, Alberta, Canada). Outcomes Adjudication and Data Safety and Monitoring Committees will be
Conflict of interest
None reported.
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