The current study sought to prolong the observational interval after initiating medication with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an indicator of autonomic nervous system function in patients with RR-MS.
Fingolimod (Gilenya®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) is a novel oral disease-modifying therapy that acts as a sphingosine-1-phosphate (S1P) receptor agonist and reduces the recirculation of lymphocytes to blood and peripheral tissues, including inflammatory lesions. A critical part of fingolimod therapy still remains in the screening and initiation phases because of the risk of cardiac events. It is well known that the first dose of fingolimod is associated with a decrease in heart rate (HR) and slowing of atrioventricular (AV) conduction. Patients were continuously observed for a minimum of 6 hours after taking fingolimod. Because resurgence of heart rate began at 6 hours, the actual recommendation for observation is only 6 hours. Data about the effect of fingolimod after this time period is lacking.
Study Type
OBSERVATIONAL
Enrollment
100
This is a prospective cohort-based study. Eligible are all patients planned for a treatment with fingolimod at the Hamburg University Hospital who are willing and able to participate in an observational study.
University Medical Hospital Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGRecurrence of AF
Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation
Time frame: 6 months follow up
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