Multiple Sclerosis
Conditions
Keywords
Heart Rhythm, Fingolimod, autonomic nervous system, Effects of Medicinal Substance
Brief summary
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.
Detailed description
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.
Interventions
DRUGGilenya®; Novartis Pharmaceuticals Corporation
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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation * Individuals over the age of 18 years * Patients with relapsing-remitting forms of multiple sclerosis who were considered eligible for fingolimod treatment on a clinical basis.
Exclusion criteria
* Insufficient knowledge of the German language (not able to understand and write the German language) * Physical or psychological incapability to take part in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of AF | 6 months follow up | Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation |
Countries
Germany
Contacts
Primary ContactRuken Özge Akbulak
Backup ContactChristoph Heesen
Outcome results
None listed