Arrhythmias & electrophysiology

The Seventh Prevention of Syncope Trial (POST VII)—A randomized clinical trial of atomoxetine for the prevention of vasovagal syncope: Rationale and study design

Am Heart JPublished Rationale and design of a randomised controlled trial

Study context

Population
Patients with vasovagal syncope and ≥2 syncopal spells in the preceding yearplanned
Participants
180 patients
Planned comparison
Atomoxetine vs placebo
Primary endpoint
Proportion of patients with ≥1 syncope recurrence in each arm (ITT)
Follow-up
6-month observation period per phase
Methodological detailsmulticentre, double-blind, placebo-controlled, crossover, 1-week washout between phases, Power: assuming 33% RR reduction in syncope recurrence and 16% dropout, 180 patients give 85% power, P = .05
  • Multicentre
  • Double-blind
  • Placebo-controlled
  • Crossover
  • 1-week washout between phases
  • Power: assuming 33% RR reduction in syncope recurrence and 16% dropout, 180 patients give 85% power, P = .05

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

The Seventh Prevention of Syncope Trial (POST VII)—A randomized clinical trial of atomoxetine for the prevention of vasovagal syncope: Rationale and study design. Am Heart J. Published 24 April 2023. doi:10.1016/j.ahj.2023.04.012

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