Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

• Conditions: Multiple Sclerosis

• Registration Number: NCT03216915
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2013-06-01
• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of AF	6 months follow up	Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation

Trial Locations

Locations (1)

University Medical Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany